MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Model Number	FOS310
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	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the implant in dental site 21 had to be removed due to infection and bone loss.
Additional Manufacturer Narrative
One full osseotite parallel walled implant (fos310) was returned for investigation.Visual inspection of the as returned product identified signs of wear due to usage and substantial bone residue around the external threads and collar.However, the device had no evidence of any damage or malfunction.The device could not be functionally tested for the reported failures (bone loss & infection) since they are medical conditions.Measurements could not be taken due to the presence of bone residue on the device.Pre-existing condition noted on the per was diabetes.The reported device had been implanted on tooth # 34 (fdi) for approximately 11 years.X-ray & picture evaluation: x-ray or picture images were not provided.As a result, bone loss could not be verified.Device history record (dhr) review for the lot (695016) had revealed no deviations nor non-conformance which could have caused or contributed to bone loss and infection after implantation of the device.All products were conforming at the time they left zimmer biomet.The product was returned but the reported events (bone loss & infection) couldn't be verified since they are medical conditions.Zimmer biomet complaint number (b)(4).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.H6: event problem and evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is avaliable at the time of this report.

• Brand Name: FULL OSSEOTITE® IMPLANT 3.75 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9449930
• Report Number: 0001038806-2019-01561
• Device Sequence Number: 14196502
• Product Code: DZE
• UDI-Device Identifier: 00844868003489
• UDI-Public: (01)00844868003489(17)120614(10)695016(241)FOS310
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 02/18/2020

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: 06/14/2012
• Device Model Number: FOS310
• Device Catalogue Number: FOS310
• Device Lot Number: 695016
• 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: 02/07/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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: 74 YR