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 Information (3190)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the clinician indicated a malfunction and that the implant body cannot be removed from the fixture mount at tooth location 30.The implant was removed and another implant was placed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One tapered screw-vent implant (tsvm4h10) and mount were returned for investigation.Visual evaluation of the as returned products identified that the mount was attached to the implant and the devices were in good connection.Functional testing was performed to disengage mount from implant.The mount disengaged from implant as normal.Pre-existing patient conditions and x-ray images are irrelevant to this investigation.The implant was being placed on tooth # 30 (universal) when the incident occurred.Picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot (1226243) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (1226243) for similar events and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed following functional testing.

• 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
• MDR Report Key: 10148646
• Report Number: 0002023141-2020-00900
• Device Sequence Number: 14058576
• Product Code: DZE
• UDI-Device Identifier: 00889024343993
• UDI-Public: (01)00889024343993(17)240526(10)1226243(241)TSVM4H10
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 05/26/2024
• Device Model Number: TSVM4H10
• Device Catalogue Number: TSVM4H10
• Device Lot Number: 1226243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: 44 YR