MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.1, 8, MTX,MC,; DENTAL IMPLANT

Model Number	TSVM4H8
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
Dr.Indicated malfunction.The implant body cannot be removed from the fixture mount.The implant was removed and another implant was placed.Tooth site # 30.
Additional Manufacturer Narrative
One (1) imp, tsv, 4.1, 8, mtx,mc, (tsvm4h8) was returned for investigation.Visual evaluation of the as returned product identified minor signs of use.Functional testing to recreate the reported event verified the implant does not disengage from the mount.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on tooth # 30 (universal) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1248024).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1248024) for similar events and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: g6: checked "follow-up." h2: checked follow-up type.H3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.1, 8, MTX,MC,
• 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: 13714057
• Report Number: 0002023141-2022-00615
• Device Sequence Number: 5957011
• Product Code: DZE
• UDI-Device Identifier: 00889024344037
• UDI-Public: (01)00889024344037(17)260929(10)1248024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133339
• 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,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Expiration Date: 09/29/2026
• Device Model Number: TSVM4H8
• Device Catalogue Number: TSVM4H8
• Device Lot Number: 1248024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female