MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,MCOL MG,4.7MM,8MM; DENTAL IMPLANT

Catalog Number	TSVMWB8
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).E1: email unknown / not provided.G4: additional pma/510(k) number k101880.
Event or Problem Description
It was reported that the implant at tooth site #unk was removed as it was fractured & had also had an infection.Bone loss, infection & implant broken.
Additional Manufacturer Narrative
Zimvie received one (1) tsvmwb8, (imp, tsv, mcol mg,4.7mm, 8mm) for evaluation.Visual evaluation was performed, the implant had signs of use.Bone debris on external threads.Damage to the implant.The implant was fractured at the collar.Dhr review was completed for the subject lot number 1273136.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 1273136 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 cause determined from the investigation was patient factors.Refer to attached summary investigation for infection and bone loss.Therefore, based on the available information, a device malfunction did occur.The implant was fractured at the collar.The reported event was confirmed.Infection and bone loss are a medical condition and are non-verifiable with all the information.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.Similar complaints for infection and / or bone loss related problems have been previously investigated.Refer to attached summary investigation.Investigations performed for hundreds of events where either of these conditions, infection, or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.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.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TSV,MCOL MG,4.7MM,8MM
• 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: 23488057
• Report Number: 0001038806-2025-02981
• Device Sequence Number: 10499211
• Product Code: DZE
• UDI-Device Identifier: 00889024019812
• UDI-Public: (01)00889024019812(17)280925(10)1273136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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?: No
• Operator of Device: Other
• Device Catalogue Number: TSVMWB8
• Device Lot Number: 1273136
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• 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: 11/06/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: 63 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic