BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM X 18.0MM LOCKING CORTICAL SCREW

    MDR report key: 2476932 · Received March 5, 2012

    Report

    Report Number
    3025141-2012-00030
    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 NUMBER, PART NUMBER; 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; 3025141-2012-00024, CO-3400; 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; 3025141-2012-00031, 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 18.0MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HWC ACUMED LLC COL-3180 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1