BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 8, MTXF, MG, HA

    MDR report key: 20998921 · Received December 23, 2024

    Report

    Report Number
    0002023141-2024-04135
    Event Type
    Injury
    Date Received
    December 23, 2024
    Report Date
    April 2, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344389
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER: K101880 AND K133339.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVTWH8, (IMP, TSV, 4.7, 8, MTXF, MG, HA) FOR EVALUATION VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, AND WAS IDENTIFIED AS REPORTED WHERE MEASURED. THE IMPLANT WAS FRACTURED AT THE COLLAR REGION. BONE LOSS IS A MEDICAL CONDITION AND IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242732. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1242732 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿ & ¿BONE LOSS¿. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENTS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS. REFER TO ATTACHED SUMMARY INVESTIGATION FOR ¿BONE LOSS¿. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT (FRACTURE IMPLANT) WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. BONE LOSS IS A MEDICAL CONDITION AND IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. 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. SIMILAR COMPLAINTS FOR BONE LOSS RELATED PROBLEMS HAVE BEEN PREVIOUSLY INVESTIGATED. REFER TO ATTACHED SUMMARY INVESTIGATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS ESCAPING THE AVAILABLE DETECTIONS IS REMOTE AND ALMOST NONEXISTENT. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/ OR ANY FURTHER ESCALATIONS. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT IN SITE 30 FRACTURED AND LIKELY CAUSED CRESTAL BONE LOSS AND PAIN. PATIENT WILL NEED TO RETURN TO COMPLETE PROCEDURE. SITE WAS GRAFTED WITH ALLOGRAFT, PRIOR TO IMPLANT PLACEMENT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628194 IMP, TSV, 4.7, 8, MTXF, MG, HA DENTAL IMPLANT DZE ZIMMER DENTAL 1242732 00889024344389

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention