MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM; Dental Implant

Catalog Number	TSVB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	05/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implants at tooth sites #5 and #6 were removed due to infection and the presence of an abscess.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).\ \ a4: patient weight unknown / not provided.\ d6: d6a.If implanted, unknown.\ d10.Concomitant medical products \ tsx37b10, tsx implant, 3.7mmd, 10mml lot 2120017931.\ g4: premarket identification k013227 \ \ a summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.

• Brand Name: IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50647711
• Report Number: 0001038806-2026-04695
• Device Sequence Number: 21417437
• Product Code: DZE
• UDI-Device Identifier: 00889024019515
• UDI-Public: (01)00889024019515(17)290930(10)1289105
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: Lay User/Patient
• Device Catalogue Number: TSVB11
• Device Lot Number: 1289105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Dental Implant See H10 Narrative
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female