MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7,10,MTX,MC,MG,HA; DENTAL IMPLANT AND MOUNT

Model Number	TSVMWH10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the time of placement, the fixture mount was stuck to the implant and unable to be removed.The procedure was completed using another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional 510(k) number is k133339.Manufacturing date is unknown.
Additional Manufacturer Narrative
One (1) imp, tsv, 4.7,10,mtx,mc,mg,ha (tsvmwh10) was returned for investigation.Visual evaluation of the as returned product identified the devices could not be disengaged.Signs of use.Functional testing was performed and it was noticed that the devices could not disengage.A pre-existing condition noted on the per was moderate bone density (type ii).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.Review of appropriate documentation: document reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Information identified: warnings, precautions and breakage.Per the applicable ifu, it is stated that improper technique can cause device failure.Dhr review: dhr review for the lot (1238024) 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: complaint history review was performed for the reported lot number (1238024) for similar events (complaint category keywords: functional: does not disengage/release) and one (1) other complaint was identified under (b)(4) post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (tsvmwh10).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: IMP, TSV, 4.7,10,MTX,MC,MG,HA
• Common Device Name: DENTAL IMPLANT AND MOUNT
• 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: 12913450
• Report Number: 0002023141-2021-03452
• Device Sequence Number: 11883228
• Product Code: DZE
• UDI-Device Identifier: 00889024344143
• UDI-Public: (01)00889024344143(17)250918(10)1238024
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 09/18/2025
• Device Model Number: TSVMWH10
• Device Catalogue Number: TSVMWH10
• Device Lot Number: 1238024
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male