MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® 2 IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	XFOS585
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that after insertion of the implant at tooth site 26, the mount could not be disengaged from the implant.Manual tools were used, but in the end it was necessary to remove the implant and place another one.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned product identified the implant and mount with signs of use.Damage was seen at the mount screw, possibly from the removal process.During a functional test the mount does not disengage from the implant.A pre-existing condition noted on the per was low bone density (type iii).The reported device was located on tooth # 26 (fdi) and was used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: warnings and precautions.Dhr review : dhr review was completed for the subject lot number (2021120735).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2021120735) for similar events and no other complaint was identified.Review completed utilizing keywords: 'does not disengage/release'.Post market trending review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE® 2 IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14950294
• Report Number: 0001038806-2022-01055
• Device Sequence Number: 17871325
• Product Code: DZE
• UDI-Device Identifier: 00844868023944
• UDI-Public: (01)00844868023944(17)270110(10)2021120735
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XFOS585
• Device Catalogue Number: XFOS585
• Device Lot Number: 2021120735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female