BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø4.5 SELF-TAP L54 SST

    MDR report key: 2901288 · Received January 8, 2013

    Report

    Report Number
    8030965-2013-00067
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT EXPERIENCED A PROXIMAL FEMUR FRACTURE ON AN UNKNOWN DATE AND WAS IMPLANTED WITH AN UNKNOWN NAIL. ON (B)(6) 2012, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE NAIL AND IMPLANTATION OF A SYNTHES PLATE AND SCREWS AND BONE GRAFT. ON (B)(6) 2012, THE PATIENT FELL AND A SHARP ROTATION OF THE LIMB RE-FRACTURED THE PROXIMAL FEMUR AND THE HEADS OF THE SCREWS WERE NOTED AS BROKEN. THIS REPORT IS #6 OF 6 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8571 CORTSCR Ø4.5 SELF-TAP L54 SST CORTSCR Ø4.5 SELF-TAP L54 SST HWC SYNTHES GMBH 7581830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, PLATE, BONE GRAFT