MAUDE Adverse Event Report: ZIMMER DENTAL TWIST HA 3.25MMX10MM; DENTAL IMPLANT

Catalog Number	2130
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the physician removed a fixture mount from an implant placed in the patient's mouth and noticed that the hex of the implant body was deformed.The physician removed the fixture mount at the specified torque value.The physician removed the implant from the patient's mouth and used a different product.Tooth site #22 (universal).
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.One implant was reported and returned for investigation.Visual/physical evaluation of the as returned product identified signs of wear around the tines.The device was able to engage and disengage in-house mating device as normal.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.Zimvie will continue to monitor for trends.

• Brand Name: TWIST HA 3.25MMX10MM
• 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: 17100065
• Report Number: 0002023141-2023-01643
• Device Sequence Number: 1988874
• Product Code: DZE
• UDI-Device Identifier: 00889024013285
• UDI-Public: (01)00889024013285(17)270406(10)2021080073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093164
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: Other
• Device Catalogue Number: 2130
• Device Lot Number: 2021080073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic