BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARUS CORTICAL SCREW

    MDR report key: 384971 · Received March 25, 2002

    Report

    Report Number
    3025141-2001-00004
    Event Type
    Injury
    Date Received
    March 25, 2002
    Date of Event
    August 23, 2001
    Report Date
    March 23, 2002
    Manufacturer
    ACUMED, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS ADDRESING A HUMERAL FRACTURE BY IMPLANTING A POLARUS ROD WITH INTERLOCKING SCREWS, ONE OF THE SCREWS BROKE LEAVING 5MM OF THE SCREW TIP IN THE PATIENT'S BODY. THE SCREW IS MANUFACTURED FROM IMPLANT GRADE TITANIUM. IN ADDITION, THE SURGEON DID NOT USE A TAP INSTRUMENT WHICH HELPS TO CARVE A PATH FOR THE SCREW SO THAT LESS FORCE IS NECESSARY TO INSTALL THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARUS CORTICAL SCREW IMPLANT HWC ACUMED, INC. * W02029

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other