MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 10, MTXF, MG,HA; DENTAL IMPLANT

Model Number	TSVTWH10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Date of event: event date not provided.Pma/510k: additional 510(k) number is k133339.
Event or Problem Description
It was reported that the threads of the implant are damaged and the customer is requesting a rethreading tool to rethread the implant.Tooth #14.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
An imp, tsv, 4.7, 10, mtxf, mg,ha (tsvtwh10) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported device location was #14 and length of usage is approximately 3 years.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use for screw-vent® implants (9665 rev 0-09/14) information identified: contraindications, warnings, precautions, breakage dhr review: dhr review was completed for the subject lot number (63810097).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (63810097) for similar event and no other complaint was identified.Review completed utilizing keywords: functional : damaged threads.Post market trend review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.Sections updated: b4: date of this report.G3: date investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H6: adverse event problem codes.H10: manufacturer's narrative.

• Brand Name: IMP, TSV, 4.7, 10, MTXF, MG,HA
• 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: 13904879
• Report Number: 0002023141-2022-00724
• Device Sequence Number: 12231552
• Product Code: DZE
• UDI-Device Identifier: 00889024344341
• UDI-Public: (01)00889024344341(17)221130(10)63810097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: TSVTWH10
• Device Catalogue Number: TSVTWH10
• Device Lot Number: 63810097
• Was Device Available for Evaluation?: No
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose