BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM X 40.0MM CANCELLOUS SCREW

    MDR report key: 2476779 · Received March 5, 2012

    Report

    Report Number
    3025141-2012-00018
    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; 3025141-2012-00019; 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; 3025141-2012-00030; 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 4.0MM X 40.0MM CANCELLOUS SCREW SCREW, FIXATION, BONE HWC ACUMED LLC CA-4400 232261

    Patients

    Seq Age Sex Outcome Treatment
    1