MAUDE Adverse Event Report: ZimVie US Corp LLC IMP TM 4.7MM MTX FULL, 11.5MM; Dental Implant

Catalog Number	TMTWB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient developed peri-implantitis at tooth site 30.X-ray taken to check implant and the implant was fractured at mesh center.Removed fractured pieces of implant and bone grafted.Inflammation pain and swelling reported as a result of the event.Patient has elected to not replace the implant at this time.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a4: patient weight: unknown / not provided.G4: premarket identification pma/510(k) #: k113753|k112160.H6: event problem codes: patient code: 1994, 1932.

• Brand Name: IMP TM 4.7MM MTX FULL, 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: 50017174
• Report Number: 0001038806-2026-03894
• Device Sequence Number: 9572969
• Product Code: DZE
• UDI-Device Identifier: 00889024019041
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: TMTWB11
• Device Lot Number: 1260800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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: 74 YR
• Patient Sex: Male