MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP TM 3.7MM MTX,11.5MM; DENTAL IMPLANT

Catalog Number	TMMB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the dental implant located in position number 13 failed because it fractured at half.Implant was removed.The doctor reports that the procedure was not concluded by placing another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: a.Patient identifier a.Age at time of event a.Weight updated to unknown a.Gender b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) tmmb11, (imp tm 3.7mm mtx,11.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use.The implant was observed fractured in half, and the remaining fractured part was not returned for evaluation.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1230588.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1230588 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ based on the investigation and risk management file review, the most likely root causes determined from the investigation are parafunctional habits/patient factors, or customer error.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: IMP TM 3.7MM MTX,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 ; 5619713230
• MDR Report Key: 23678578
• Report Number: 0001038806-2025-03451
• Device Sequence Number: 8927253
• Product Code: DZE
• UDI-Device Identifier: 00889024018877
• UDI-Public: (01)00889024018877(17)240723(10)1230588
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: Other
• Device Expiration Date: 07/23/2024
• Device Catalogue Number: TMMB11
• Device Lot Number: 1230588
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic