MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	FNT510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to infection and bone loss.Patient also had inflammation.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).One full osseotite tapered implant (fnt510) and abutment were returned for investigation.The reported event occurred at tissue level; the investigation was focused only on the implant.Visual inspection of the as returned product identified minor signs of wear and bone residue around the external threads due to usage.The device could not be functionally tested for the reported failures (bone loss and infection) since they are medical conditions.Measurements could not be taken since the implant was still attached to an abutment which could not be removed since there was debris in its drive feature.Pre-existing condition noted on the product experience report (per) was moderate bone density type ii.The reported device had been implanted on tooth number 25 for approximately 6 years.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional complaints for this lot.Complainant reported perimplantitis.The reported devices were returned and the reported event is non-verifiable for both devices as pictures or x-rays were not provided by the customer.A definitive root cause could not be identified.The following sections have been updated: b4: date of this report.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change no to yes.H6: evaluation codes.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 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9411521
• Report Number: 0001038806-2019-01512
• Device Sequence Number: 16877382
• Product Code: DZE
• UDI-Device Identifier: 00844868003373
• UDI-Public: (01)00844868003373(17)171114(10)2012110238(241)FNT510
• Combination Product (Y/N): N
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/12/2020

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: 11/14/2017
• Device Model Number: FNT510
• Device Catalogue Number: FNT510
• Device Lot Number: 2012110238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 56 YR
• Patient Weight: 80