MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,4.1MM,SBM,11.5; DENTAL IMPLANT

Catalog Number	TSV4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Zimvie employee reports through email that the clinic informed them of a fractured implant at the head part, and the implant was removed.It was reported that the implant had mobility and that they discovered through an rx that it was due to implant fracture.They also indicate the implant was loose.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A4: patient weight: unknown / not provided.D1: brand name unknown / provided.D4: additional device information: unknown / not provided.G4: premarket identification pma/510(k) #: unknown / not provided.H4: device manufacturer date: unknown / not provided.
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: b4: date of event.B4: date of this report.B5: describe event or problem.D1: brand name.D4: additional device information.D6a: if implanted, give date.D6b: if explanted, give date.G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type?.H4: device manufacture date.H10: additional narrative.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tsv4b11, (imp,tsv,4.1mm,sbm,11.5)), for evaluation.Visual evaluation was performed, a fracture has been identified on the implants collar.Dhr review was completed for the subject lot number 1265726.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 1265726, for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : implant¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was clinician selects implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the collar.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP,TSV,4.1MM,SBM,11.5
• 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: 23776505
• Report Number: 0001038806-2025-03748
• Device Sequence Number: 9933821
• Product Code: DZE
• UDI-Device Identifier: 00889024019232
• UDI-Public: (01)00889024019232(17)280322(10)1265726
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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 Catalogue Number: TSV4B11
• Device Lot Number: 1265726
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/05/2025
• 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; Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/29/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic