MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	XIFOSM311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Email address was not provided.
Event or Problem Description
It was reported that the implant at tooth sites 14 was removed due to pain.Symptoms as a result of the event: sensitivity.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Two (2) osseotite® certain® 2 implant 3.25 x 11.5mm (xifosm311) & one (1) osseotite® certain® 2 implant 4 x 11.5mm (xifoss411) were returned for investigation.Visual evaluation of the as returned products identified no apparent malfunction with the implants, besides the cover screw not being able to be disengaged.There are heavy scratches on the cover screw head.Signs of use on the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Device history record (dhr) review was completed for the subject lot numbers (2018011764 & 2018040215).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2018011764 & 2018040215) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10769707
• Report Number: 0001038806-2020-01711
• Device Sequence Number: 1901740
• Product Code: DZE
• UDI-Device Identifier: 00844868023098
• UDI-Public: (01)00844868023098(17)230213(10)2018011764(241)XIFOSM311
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 02/13/2023
• Device Model Number: XIFOSM311
• Device Catalogue Number: XIFOSM311
• Device Lot Number: 2018011764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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: 57 YR