MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 3.7, 10,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMH10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a clinical procedure, the implant body could not be removed from the fixture mount.The implant was removed and another implant was placed.Tooth site # 21.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 3331, 4109 and 4111.H6: investigation findings code was added: 180.H6: investigation conclusions codes were added: 4307.One (1) imp, tsv, 3.7, 10,mtx,mc,mg,ha (tsvmh10) was returned for investigation.Visual evaluation of the as returned product identified signs of use.The reported event was confirmed following visual evaluation and functional testing.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (1237964).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1237964) for similar events and no other complaint was identified.Functional testing was performed.The mount was stuck to the implant and could not be disengaged.Therefore, the reported event was recreated.Based on the investigation, the potential cause for the reported event are implant and abutment/screw are not mated properly by customer, causing assembly failure and incorrect assembly of the abutment/mount to the implant.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMP, TSV, 3.7, 10,MTX,MC,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: 14167273
• Report Number: 0002023141-2022-00953
• Device Sequence Number: 14699544
• Product Code: DZE
• UDI-Device Identifier: 00889024344099
• UDI-Public: (01)00889024344099(17)250803(10)1237964
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 08/03/2025
• Device Model Number: TSVMH10
• Device Catalogue Number: TSVMH10
• Device Lot Number: 1237964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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: 52 YR
• Patient Sex: Male