MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,4.1MM,13M; DENTAL IMPLANT

Catalog Number	TSVM4B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
Customer reported nerve damage tooth #20.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie received one implant for evaluation.Visual evaluation was performed, there was signs of use with bone debris on the external threads.No malfunctions detected that could lead to reported event.Device was measured with a caliper and matched print specifications.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.Passed sterilization.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, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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 or corrected information to report.

• Brand Name: IMP,TSV,MCOL MG,4.1MM,13M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17797899
• Report Number: 0002023141-2023-02605
• Device Sequence Number: 5761904
• Product Code: DZE
• UDI-Device Identifier: 00889024019645
• UDI-Public: (01)00889024019645(17)270607(10)1255373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TSVM4B13
• Device Lot Number: 1255373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic