BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING PLATE, CURVED A, 8-HOLE

    MDR report key: 7987517 · Received October 19, 2018

    Report

    Report Number
    2031009-2018-00045
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 25, 2018
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188100765
    PMA / PMN Number
    K060041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    TRIMED RECEIVED THE FOLLOWING REPORT OF (B)(6) 2018 FROM TRIMED SALES MEMBER LOCATED IN THE UNITED STATES, REGARDING THE LOCKING PLATE, CURVED A, 8-HOLE: DURING A POST-OPERATIVE X-RAY SCAN, IT WAS DISCOVERED THAT LOCKING, CURVED A, 8-HOLE (PCA8) HAD BROKEN AND WOULD NEED TO BE EXPLANTED ON (B)(6) 2018. TRIMED HAS CONTACTED THE SALES MEMBER MORE THAN THREE TIMES TO GETHER FURTHER INFORMATION REGARDING THIS COMPLAINT AND THE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED TO TRIMED FOR THIS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828291 LOCKING PLATE, CURVED A, 8-HOLE LOCKING PLATE, CURVED A, 8-HOLE HRS TRIMED, INC. PCA8 00842188100765

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown