MAUDE Adverse Event Report: ZimVie US Corp LLC TSX IMPLANT, 4.1MMD, 11.5MML; Dental Implant

Catalog Number	TSX41B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an implant was removed due to a fracture resulting from trauma.Patient suffered from inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided a4: patient weight: unknown / not provided b3: date of event: unknown / not provided d6: d6a.If implanted, give date: unknown.

• Brand Name: TSX IMPLANT, 4.1MMD, 11.5MML
• 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: 50054458
• Report Number: 0001038806-2026-03978
• Device Sequence Number: 13131981
• Product Code: DZE
• UDI-Device Identifier: 00844868045106
• UDI-Public: (01)00844868045106(17)300925(10)2120038092
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220978
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: Lay User/Patient
• Device Catalogue Number: TSX41B11
• Device Lot Number: 2120038092
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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 Sex: Male