MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM; DENTAL IMPLANT

Catalog Number	TSV6B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #31 was removed due to fracture.The patient experienced a broken implant crown while eating a sandwich and presented for an emergent procedure.The implant was removed with a trephine bur and the site was regrafted.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number ¿ k011028|k013227.Zimvie received the reported implant for evaluation.Visual evaluation off the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.The implant was identified fractured at the collar region.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.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 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are 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, 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: IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM
• 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: 22772108
• Report Number: 0002023141-2025-02206
• Device Sequence Number: 9621443
• Product Code: DZE
• UDI-Device Identifier: 00889024019393
• UDI-Public: (01)00889024019393(17)210831(10)63430645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 08/11/2025

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: 08/31/2021
• Device Catalogue Number: TSV6B13
• Device Lot Number: 63430645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ZIMMER ABUTMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic