3I Form Biomet PDF Details

The 3I Biomet form is a warranty and complaint document used to report incidents involving Biomet 3I dental implants. It serves a dual purpose: satisfying FDA Medical Device Reporting requirements and initiating Biomet 3I's internal warranty and replacement process for documented implant failures.

Who Needs the 3I Biomet Warranty Form

This form is used by dental practitioners, oral surgeons, and clinics that place Biomet 3I implants. Any professional who observes a reportable adverse event - including non-integration, loss of the implant, or trauma-related failure - must complete and submit this form to Biomet 3I's Regulatory Services in Palm Beach Gardens, FL. Facilities that handle related documentation such as an ADA dental claim form may need this warranty report as supporting evidence for the patient record.

What the Form Documents

The 3I Biomet form collects information in four key areas:

Regulatory and Compliance Context

Under 21 CFR Part 803, healthcare facilities and manufacturers must report device-related adverse events to the FDA. The 3I Biomet form satisfies this requirement for implant-related incidents. It functions similarly to a reportable event form required by many state health departments, and follows the same general adverse event documentation structure as an adverse action form. Proper completion protects the dental practice from compliance gaps and ensures the patient's incident is on record.

Device Return and Submission

When an implant is returned as part of a warranty claim, it must be sterilized before shipping under United States Postal Regulations. The completed form and the sterilized device are sent to Biomet 3I's Regulatory Services team. Practitioners managing follow-up care for affected patients may also need a dental treatment consent form if the patient requires further intervention after implant removal.

QuestionAnswer
Form Name3I Form Biomet
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other names3i warranty forms, information 3i form, 3i biomet implant return form, bimet3i
Form PurposeDental implant warranty claim and FDA MDR adverse event reporting
Submission addressBiomet 3I Regulatory Services, Palm Beach Gardens, FL

Form Preview Example

Warranty Form

For 3I use only:

Incident No._______________________

 

Replacement Order No. _____________

To comply with Regulatory requirements for Medical Device Reporting, it is necessary to obtain information regarding this event. Please review and provide, with as much detail as possible, the following information.

For clarity, please print or type. Please place each case on a separate Complaint Form.

ACCOUNT INFORMATION

Reporter’s Name ____________________________

 

 

BIOMET 3I Account No: _____________________

 

 

Customer Name:_____________________________

 

 

Address

_____________________________

Phone Number: (

) ________________________

City

_____________________________

Fax Number (

) ___________________________

State

____________ Zip Code__________

E-mail address________________________________

Patient’s Initials or ID No.:

_______________________________________________

Age: __________

 

 

 

 

 

 

 

 

 

 

 

 

DEVICE INFORMATION:

 

 

 

 

 

Please provide the following information:

 

 

 

 

Catalog No.

Lot No.

Quantity

Placement Date Removal Date

Tooth Site No. *Replacement request

____________ _____________

________

____________

____________

___________

_________________

____________ _____________

________

____________

____________

___________

_________________

____________ _____________

________

____________

____________

___________

_________________

*If you do not want the exact product as replacement, please specify the product code of choice.

EVENT INFORMATION:

Did this incident lead to a death or serious injury? [ ] YES [ ] NO

Note: Serious injury is defined as (1) life threatening, (2) results in permanent impairment of a body function or structure or,

(3)necessitates medical or surgical intervention by a healthcare professional to preclude permanent impairment of a body function or structure.

What was the cause of the event?

 

 

 

[ ] Trauma or Accident

[

] Non-Integration

 

[

] Infection

[ ] Loss of Integration

 

[

] Device Malfunction

[

] Device Fracture

 

[

] Biomechanical Overload/Stress

[ ] Handling-loss of sterility

 

[

] Other _______________________

 

 

 

If this event involved an implant, was the implant:

[

] Not yet restored

[ ] Restored

Page 1 of 2

M05.01.01.01 Rev 7

Warranty Form

For 3I use only:

Incident No._______________________

 

Replacement Order No. _____________

For Implants only:

 

 

 

1)

Did the patient present with any relative patient profile? (check all that apply)

 

 

□ Smoker

□ Osteoporosis

□ Diabetes

□ Other_____________

2)

Please describe the density of the bone:

 

 

 

□ High density (Type I)

□ Moderate density (Type II) □ Low density (Type III or IV)

3)Was the implant placed in a previously or simultaneously grafted site?

□No □ Yes: (describe material below)

 

 

□ Autogenous

□ Allograft

□ Xenograft

□ Alloplast

□ Hybrid

4)

Was the implant placed into an immediate extraction site?

□ No

□ Yes

 

5)

Please describe the implant placement protocol:

 

 

 

 

 

□ Single Stage (transgingival)

□ Two Stage (submerged)

 

 

6)

Was the implant loaded (provisional or final) prior to failure?

 

 

 

 

□ No

□ Yes: □ Immediate Loading (within 48 hours)

 

 

□Early Loading (within 8 weeks)

□Traditional- Delayed (3-4 months mandible, 4-6 months maxilla)

Please record any additional information concerning the event

_________________________________________________________________________________________________

_________________________________________________________________________________________________

Remedial actions taken or required to be taken: What additional treatment was taken in response to this incident? Is additional remedial treatment planned? Please Describe.

_________________________________________________________________________________________________

If required, can copies of pre/post operative radiographs/treatment records be provided? [ ] Yes [ ] No

______________________________________________________

___________________

Doctor’s Signature

Date

Doctor: Please make a copy of this report for your files and forward the original to 3I with all devices. To protect you and 3I, all used devices must be sterilized prior to mailing. Non-sterile devices may be considered biological hazards based on current United States Postal Regulations. Please send in padded mailer.

Send To:

BIOMET 3I

Regulatory Services/Implant Warranty

4555 Riverside Drive,

Palm Beach Gardens, FL 33410

Phone: (800)443-8166 Fax: (561)514-6316

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M05.01.01.01 Rev 7

How to Edit 3I Form Biomet Online for Free

Complete the Biomet 3i complaint form online using the FormsPal® PDF tool. No software download is required. Follow these steps to fill out the 3I Biomet form accurately:

Step 1: Click the "Get Form" button above. It will open the PDF editor so you can begin filling in your form.

Step 2: The PDF editor lets you do more than fill blank fields. Add customized text, adjust original content, insert graphics, and sign the document when ready.

This document requires specific information, so take time to enter each field correctly.

1. Fill out the biomet 3i complaint form with all required fields. Review the entire form before moving to the next section.

biomet 3i encode form completion process clarified (stage 1)

2. Complete the following fields: Warranty Form To comply with, NonIntegration Loss of, If this event involved an implant, M Rev, and Restored.

If this event involved an implant, Restored, and NonIntegration Loss of inside biomet 3i encode form

Double-check the implant event fields before continuing - errors in this section can delay the warranty claim.

3. This section covers patient-specific implant conditions: For Implants only - Did the patient, Smoker, Osteoporosis, Diabetes, Other, Yes, No, High density Type I, Xenograft Alloplast, Hybrid, Single Stage transgingival Two, No Yes describe material below, Autogenous Allograft, and Moderate density Type II Low. Fill in every field that applies.

Best ways to fill in biomet 3i encode form step 3

4. Complete the final section: Please describe the density of, Date, Send To, BIOMET i, Regulatory ServicesImplant Warranty, Riverside Drive, Palm Beach Gardens FL, and Phone Fax. These fields identify the submission address and contact information for Biomet 3I's Regulatory Services team.

Completing part 4 in biomet 3i encode form

Step 3: After completing all fields, click "Done" to save and download your form. Create a FormsPal account to access the biomet 3i complaint form at any time. All changes are saved automatically.

Common Questions About the 3I Form Biomet

What is the 3I Form Biomet used for?

The 3I Form Biomet is the official Biomet 3I dental implant warranty and complaint form. Dental professionals use it to report adverse events under FDA Medical Device Reporting (MDR) rules and to request a warranty replacement for a failed implant. It is submitted to Biomet 3I's Regulatory Services along with the returned device when available.

Who should complete the Biomet 3i warranty form?

Any dental practitioner, oral surgeon, or clinic that placed a Biomet 3I implant and observed a non-integration event, implant failure, or device malfunction must complete this form. Related documentation includes the ADA dental claim form and, for follow-up care, a dental treatment consent form.

Is the 3I Biomet form available online?

Yes. FormsPal provides a free online PDF editor to fill out the 3I Biomet form directly in your browser. Once complete, download the signed PDF and mail it to Biomet 3I's Regulatory Services department in Palm Beach Gardens, FL.

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