MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,6.0MM,13MM,MTX; DENTAL IMPLANT

Model Number	TSVM6B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Weight unknown / not provided.Pma/510(k) number: k101880.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
It was reported that the implant on tooth site #3 was loose during a follow up appointment and removed due to a fracture.Symptoms as a result of the event: pain, inflammation and bone loss.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One imp, tsv, mcol mg, 6.0mm, 13mm, mtx (tsvm6b13) was returned for investigation.Visual evaluation of the product identified signs of use.Bone debris on external threads.Fractured collar was identified.Bone loss could not be verified.Summary investigation attached in complaint.Functional testing could not be performed since the product was fractured.Pre-existing condition noted on the per was low bone density ¿ type iii, bruxism, and placed on a previously allografted site.The reported device had been placed on tooth #3 (universal) for approximately 4 years.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot (1220484) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1220484) for similar events and no other complaint was identified.Mar post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction (fracture) did occur, and the reported event was confirmed.Bone loss could not be verified.Summary investigation attached in complaint.The following sections have been updated: g6: checked "follow-up." h3: changed "no" to "yes.".

• Brand Name: IMP,TSV,MCOL MG,6.0MM,13MM,MTX
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16462909
• Report Number: 0002023141-2023-00657
• Device Sequence Number: 12399079
• Product Code: DZE
• UDI-Device Identifier: 00889024019690
• UDI-Public: (01)00889024019690(17)231004(10)1220484
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/04/2023
• Device Model Number: TSVM6B13
• Device Catalogue Number: TSVM6B13
• Device Lot Number: 1220484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male