3I Form Biomet PDF Details

In the landscape of medical devices, especially those concerning dental implants, the importance of maintaining stringent quality control and customer satisfaction is paramount. Enter the 3I Biomet form, a warranty document meticulously designed to streamline the process of reporting and addressing incidents involving Biomet 3I's products. This form serves dual purposes. First, it complies with regulatory requirements for Medical Device Reporting, ensuring that any event, whether leading to a serious injury or not, is thoroughly documented and investigated. The form is detailed, asking for comprehensive information on the reporter, the device in question, and the event itself—ranging from trauma to device malfunction. This not only facilitates a better understanding of what went wrong but also aids in the continuous improvement of their products. Additionally, the form delves into the specifics of the patient's profile and the conditions of the implant's placement, providing valuable data on factors that might influence the device's performance. The requirement for the device to be sterilized before being sent back, in compliance with United States Postal Regulations, underscores the meticulous attention to safety and hygiene standards. By offering a clear path for reporting and remediation, the 3I Biomet form symbolizes a commitment to excellence and patient well-being in the dental implant industry.

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 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

Page 2 of 2

M05.01.01.01 Rev 7

How to Edit 3I Form Biomet Online for Free

You are able to complete biomet 3i complaint form without difficulty with our PDFinity® online PDF tool. Our tool is constantly evolving to provide the very best user experience attainable, and that is because of our dedication to constant development and listening closely to feedback from users. Starting is effortless! All you need to do is adhere to the following simple steps below:

Step 1: Click the "Get Form" button above. It will open up our pdf tool so that you could begin filling in your form.

Step 2: With this online PDF editor, you may do more than merely fill out blank form fields. Edit away and make your forms seem high-quality with customized text incorporated, or adjust the file's original content to excellence - all accompanied by the capability to insert any kind of graphics and sign the document off.

This document requires specific info to be filled in, therefore ensure you take the time to type in what is expected:

1. Fill out the biomet 3i complaint form with a selection of necessary blank fields. Consider all the information you need and be sure there is nothing forgotten!

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

2. Your next part would be to fill in these blanks: 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

It is possible to make an error while completing the If this event involved an implant, consequently make sure to take another look before you'll send it in.

3. This next segment is focused on For Implants only Did the patient, Smoker, Osteoporosis, Diabetes, Other, Yes, No, 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 one of these blank fields.

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

4. Filling in Please describe the density of, Date, Send To, BIOMET i, Regulatory ServicesImplant Warranty, Riverside Drive, Palm Beach Gardens FL , and Phone Fax is crucial in this section - always be patient and be mindful with each field!

Completing part 4 in biomet 3i encode form

Step 3: Right after going through the fields and details, click "Done" and you are good to go! Join FormsPal now and easily get access to biomet 3i complaint form, available for download. All alterations made by you are preserved , meaning you can edit the document later on if needed. Here at FormsPal.com, we do our utmost to make certain that all of your details are stored private.

3I Form Biomet isn’t the one you’re looking for?

Related Documents