BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX,10MM

    MDR report key: 13385899 · Received January 28, 2022

    Report

    Report Number
    0002023141-2022-00185
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018808
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K113753 / K112160.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. SINCE PRODUCTS HAVE NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PRODUCT EXPERIENCE REPORT (PER). X-RAY OR PICTURE WAS NOT PROVIDED. THE REPORTED DEVICE WAS LOCATION ON TOOTH #13 AND WAS USED FOR APPROXIMATELY 3 YEARS. A DEVICE HISTORY RECORD (DHR)REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED THAT THE IMPLANT FRACTURED IN THE PATIENT'S MOUTH. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT FRACTURED IN THE PATIENT'S MOUTH. THE IMPLANT WAS PLACED CLOSED TO THE SINUS AND AT THIS POINT IN ORDER TO AVOID PERFORATION, THE IMPLANT WILL STAY IN THE PATIENTS MOUTH. THEY WILL CALL AT A LATER DAT IF THEY DECIDE TO REMOVE IT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510465 IMP TM 4.1MM MTX,10MM DENTAL IMPLANT DZE ZIMMER DENTAL TMM4B10 63541562 00889024018808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown