BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED LOCKING SCREW75MM

    MDR report key: 3037585 · Received April 5, 2013

    Report

    Report Number
    2520274-2013-01840
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: HTY, JDW. 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.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED APPROXIMATELY 3 WEEKS AGO WITH A PLATE AND SCREWS FOR A PERI FEMUR FRACTURE. X-RAYS TAKEN ON AN UNKNOWN DATE INDICATE BOTH THE LOCKING AND CONICAL SCREWS HAVE BACKED OUT AND PLATE IS OFF THE BONE. THE PATIENT IS REPORTEDLY OBESE WITH VERY POOR BONE QUALITY AND OTHER HEALTH ISSUES. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR REVISION. THIS REPORT IS #4 OF 6 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140028 5.0MM CANNULATED LOCKING SCREW75MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention