MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 8,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMWH8
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.K133339.
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 #15.
Additional Manufacturer Narrative
H6: method code was added: 3331 and 4109.H6: results code was added: 180.H6: conclusions code was added: 4307.H10: narrative/data was updated.The reported device was received for evaluation.The reported condition of implant body cannot be removed from fixture mount was confirmed.Visual evaluation of the as returned products identified minor signs of wear due to usage.Functional testing revealed that the mount was stuck to the implant and could not be disengaged with hand tools.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP, TSV, 4.7, 8,MTX,MC,MG,HA
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10485144
• Report Number: 0002023141-2020-01348
• Device Sequence Number: 14446570
• Product Code: DZE
• UDI-Device Identifier: 00889024344181
• UDI-Public: (01)00889024344181(17)240325(10)1224376(241)TSVMWH8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101880
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 03/25/2024
• Device Model Number: TSVMWH8
• Device Catalogue Number: TSVMWH8
• Device Lot Number: 1224376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: 60 YR