MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,4.1MM,SBM,11.5; DENTAL IMPLANT

Catalog Number	TSV4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4), a4: weight unknown / not provided.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #30 fractured and was removed.Patient lost implant crown earlier this year, which was recorded against a separate complaint.A new screw was ordered to attach the crown to the implant.While trying to retrieve the screw, it was noticed that the whole buccal side of the implant was broken and was unable to be restored again.An additional appointment was required to replace the implant.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.Zimvie did not receive the reported device for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.This complaint refers to the specific device being investigated for this complaint record.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.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are parafunctional habits/patient factors, or customer error.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.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,4.1MM,SBM,11.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23638848
• Report Number: 0001038806-2025-03361
• Device Sequence Number: 9821256
• Product Code: DZE
• UDI-Device Identifier: 00889024019232
• UDI-Public: (01)00889024019232(17)220331(10)63600202
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: TSV4B11
• Device Lot Number: 63600202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic