MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 8, MTXF, MG, HA; DENTAL IMPLANT

Catalog Number	TSVTWH8
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: pma/510(k) number: k101880 and k133339.
Event or Problem Description
It was reported that the implant in site 30 fractured and likely caused crestal bone loss and pain.Patient will need to return to complete procedure.Site was grafted with allograft, prior to implant placement.
Additional Manufacturer Narrative
Zimvie received one (1) tsvtwh8, (imp, tsv, 4.7, 8, mtxf, mg, ha) for evaluation visual evaluation of the as returned device identified the implant with signs of use, and was identified as reported where measured.The implant was fractured at the collar region.Bone loss is a medical condition and is non-verifiable with the information provided.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1242732.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1242732 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ & ¿bone loss¿.The customer did not submit images for the reported events.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root causes determined from the investigation are parafunctional habits/patient factors.Refer to attached summary investigation for ¿bone loss¿.Therefore, based on the available information, a device malfunction did occur.The reported event (fracture implant) was confirmed with all the available information.Bone loss is a medical condition and is non-verifiable with the information provided.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 bone loss related problems have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.Furthermore, the probability of manufacturing or design defects that might lead to bone loss escaping the available detections is remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.7, 8, MTXF, 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20998921
• Report Number: 0002023141-2024-04135
• Device Sequence Number: 9896563
• Product Code: DZE
• UDI-Device Identifier: 00889024344389
• UDI-Public: (01)00889024344389(17)260513(10)1242732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/02/2025

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 Expiration Date: 05/12/2026
• Device Catalogue Number: TSVTWH8
• Device Lot Number: 1242732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• 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: 12/23/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic