BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 19967300 · Received August 12, 2024

    Report

    Report Number
    0002023141-2024-02685
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 21, 2024
    Report Date
    January 20, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013162
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). ZIMVIE RECEIVED ONE (1) 1993, (IMPL TWIST MP-1 5.0 MM 8 MM) FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED, IMPLANT SHOWS SLIGHT WEAR HOWEVER MOUNT WAS ABLE TO DISENGAGE FROM IMPLANT AS INTENDED. NO MALFUNCTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2022120063. 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 2022120063 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL: FUNCTIONAL: DOES NOT DISENGAGE/RELEASE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE MOUNT WAS ABLE TO DISENGAGE FROM IMPLANT AS INTENDED. THE COOB / EVENT WERE UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). A2: PATIENT AGE IS NOT PROVIDED / UNKNOWN. A4: PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. E1: INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. G4: ADDITIONAL 510(K) NUMBER IS K962106.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT MOUNT DID NOT COME OFF. REPLACED WITH A DIFFERENT IMPLANT. TOOTH SITE # 27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216723 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2022120063 00889024013162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose