MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,8,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVT6B8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic complaining of a loose implant crown.Upon inspection, the implant at tooth location #3 suffered bone loss and loss of integration with infection.The implant was removed immediately to allow healing.Symptoms as a result of the event: loss of integration, pain, edema, inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.G4: additional pma/510(k) number ¿ k101880.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: IMP,TSV,6.0,8,MTX,MG
• 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: 21514742
• Report Number: 0002023141-2025-00550
• Device Sequence Number: 11909789
• Product Code: DZE
• UDI-Device Identifier: 00889024019911
• UDI-Public: (01)00889024019911(17)250402(10)1235953
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 04/01/2025
• Device Catalogue Number: TSVT6B8
• Device Lot Number: 1235953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic