BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM X 40.0MM CORTICAL SCREW

    MDR report key: 2476761 · Received March 5, 2012

    Report

    Report Number
    3025141-2012-00024
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Report Date
    February 1, 2012
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDWATCH FORMS ASSOCIATED WITH THIS INCIDENT ARE: MDR NUMBERS AND PART NUMBERS : 3025141-2012-00015 - 70-0147; 3025141-2012-00016 - 70-0229; 3025141-2012-00017 - CA4140 ; 3025141-2012-00018 - CA-4400; 3025141-2012-00019 - CO-3200; 3025141-2012-00020 - CO-3220; 3025141-2012-00021 - CO-3260; 3025141-2012-00022 - CO-3320; 3025141-2012-00023 - CO-3380; 3025141-2012-00025 - CO-3400; 3025141-2012-00026 - COL-3120; 3025141-2012-00027 - COL-3120; 3025141-2012-00028 - COL-3160; 3025141-2012-00029 - COL-3180; 3025141-2012-00030 - COL3180; 3025141-2012-00031 - COL-3200; 3025141-2012-00032- COL-3380; 3025141-2012-00033 - WS-1607ST; 3025141-2012-00034 - WS-1607ST; 3025141-2012-00035 - WS-1607ST.

    Description of Event or Problem · 1

    PATIENT ALLEGEDLY REJECTING IMPLANTED ANKLE PLATE AND/OR OTHER IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM X 40.0MM CORTICAL SCREW SCREW, FIXATION, BONE HWC ACUMED LLC CO-3400 230518

    Patients

    Seq Age Sex Outcome Treatment
    1