MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	FNT413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported implant removed due to perimplantitis.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite tapered implant (fnt413) was returned for investigation.Visual inspection of the as returned product identified that the device was damaged around the external hex and the collar there were noticeable wear due to usage around the external threads.The damages on the device was possibly due to the removal process.Functional testing was not performed since the device was damaged and could not be functionally tested for a medical condition failure (peri-implantitis).The reported device had been implanted on tooth for approximately 2 years.Pre-existing condition noted on the per was moderate bone density ¿ type ii.X-ray image was not provided.Device history record was performed and no related non-conformances were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported perimplantitis.The product was returned.The reported perimplantitis.The reported events could not be verified with the information provided.A definitive root cause could not be identified.The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® TAPERED IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9400072
• Report Number: 0001038806-2019-01502
• Device Sequence Number: 3231498
• Product Code: DZE
• UDI-Device Identifier: 00844868003342
• UDI-Public: (01)00844868003342(17)211125(10)2016110882(241)FNT413
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2021
• Device Model Number: FNT413
• Device Catalogue Number: FNT413
• Device Lot Number: 2016110882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR