MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7, 11, MTXF, MG,HA; DENTAL IMPLANT

Catalog Number	TSVTWH11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number k133339.
Event or Problem Description
It was reported patient fractured collar of the implant.Removed and grafted.Tooth 19.The implant was being removed because the collar fractured.The crown and abutment were removed prior to attempting to remove the failed implant.
Additional Manufacturer Narrative
Zimvie received one (1) tsvtwh11, implant, tsv, 4.7mmd, 11.5mml, micro grooves, mtx full, ha for evaluation.Visual evaluation was performed.Damage to the implant collar was identified.Bone debris on external threads.The implants collar was fractured.A fractured screw stuck inside the implant.Dhr review was completed for the subject lot number 63969719.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 63969719 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : implant¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00541-haz rev 4, the most likely root cause determined from the investigation was long-term parafunctional habits (e.G., clenching, bruxism, and overloading) of the patient over the implantation period ¿ patient factors.Therefore, based on the available information, device malfunction did occur.The implant¿s collar was fractured, and the reported event was confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.7, 11, MTXF, MG,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: 21172458
• Report Number: 0002023141-2025-00138
• Device Sequence Number: 13146337
• Product Code: DZE
• UDI-Device Identifier: 00889024344358
• UDI-Public: (01)00889024344358(17)230331(10)63969719
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: TSVTWH11
• Device Lot Number: 63969719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• 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: 01/16/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic