MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,DUAL SEL,HA; DENTAL IMPLANT

Catalog Number	TSV4H11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the dental implant located in position number 36 failed because it fractured by the hexagon.The doctor reports that the procedure was concluded by placing another implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided.A4: patient weight: unknown / not provided.D4: additional device information: 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 this report.B5: describe event or problem.D4: additional device information.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) tsv4h11, (imp,tsv,4.1mm,dual sel,ha) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone/tissue attached to external threads.The implant was observed fractured at the collar region.Some damage around the external surface/threads was seen likely due to the removal process.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.Device history record (dhr) review was completed for the subject lot number 63996185.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 63996185 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 cause determined from the investigation is parafunctional habits/patient factors.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.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.

• Brand Name: IMP,TSV,4.1MM,DUAL SEL,HA
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22960948
• Report Number: 0002023141-2025-02416
• Device Sequence Number: 12894191
• Product Code: DZE
• UDI-Device Identifier: 00889024019317
• UDI-Public: (01)00889024019317(17)230430(10)63996185
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 10/17/2025

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: 04/30/2023
• Device Catalogue Number: TSV4H11
• Device Lot Number: 63996185
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/11/2025
• 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: 09/04/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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: Unknown
• Patient Ethnicity: Non Hispanic