MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.1, 1, MTX,MC,; DENTAL IMPLANT

Model Number	TSVM4H10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant body cannot be removed from the fixture mount.The implant was removed and another implant was placed.Tooth site #20.
Additional Manufacturer Narrative
One imp, tsv, 4.1, 1, mtx, mc, (tsvm4h10) with packaging was returned for investigation.Visual evaluation of the as returned product identified signs of use but no apparent malfunction identified.Packaging seal was already opened as well.Functional testing was performed and the mount was normally disengaged from the implant.Pre-existing condition noted on per was type iv (low) bone density and tooth location was #20 (universal).The implant was placed and removed same day.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot (1236004) 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 zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Additionally, the dhr for lot 1236004 was further reviewed show that the lot was verified to be conforming to specifications complaint history review by lot number (1236004) was performed for similar events and no other similar complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.Additionally, coob could not be verified with the information available.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.1, 1, 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: 12344615
• Report Number: 0002023141-2021-02224
• Device Sequence Number: 4633545
• Product Code: DZE
• UDI-Device Identifier: 00889024343993
• UDI-Public: (01)00889024343993(17)250622(10)1236004
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/31/2022

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: 06/22/2025
• Device Model Number: TSVM4H10
• Device Catalogue Number: TSVM4H10
• Device Lot Number: 1236004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• 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: 07/30/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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: 73 YR
• Patient Sex: Male