BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2923307 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00493
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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 AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). IMPLANTS REMOVED 3 MONTHS POST IMPLANTATION. CORRECTED DATA DATE OF EVENT IS UNKNOWN BRAND NAME IS UNKNOWN, AS THE CATALOG # OF THE SCREW IS UNKNOWN. CONCOMITANT DEVICE SHOULD NOT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    HOSPITAL IN (B)(6) REPORTED A PATIENT WAS IMPLANTED WITH AN LCP DISTAL FEMUR PLATE FOR A PROXIMAL FEMUR FRACTURE ON AN UNKNOWN DATE. X-RAYS SHOW FOUR MIGRATING SCREWS AND ONE BROKEN SCREW. REPORTEDLY THE IMPLANTS CURRENTLY REMAIN IN THE PATIENT. THIS REPORT IS #2 OF 6 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE BROKE POSTOPERATIVELY. THE IMPLANTS WERE REMOVED 3 MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30298 SCREW SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PLATE, SCREWS