BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 12567230 · Received October 4, 2021

    Report

    Report Number
    0002023141-2021-02752
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 22, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018952
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (DAMAGED). THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. 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 ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED THAT THE INTERNAL IMPLANT THREADS WERE DAMAGED DURING A CLINICAL PROCEDURE. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' H6: EVALUATION CODES.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL IMPLANT THREADS WERE DAMAGED DURING A CLINICAL PROCEDURE AND IS REQUESTING TOOL ITEM # 0493 TO RE THREAD. THE IMPLANT IS WELL SEATED AND INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469192 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B13 1236881 00889024018952

    Patients

    Seq Age Sex Outcome Treatment
    1 Male