BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS

    MDR report key: 3291842 · Received August 16, 2013

    Report

    Report Number
    2520274-2013-04917
    Event Type
    Injury
    Date Received
    August 16, 2013
    Report Date
    July 23, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT CASE #(B)(6). ADDITIONAL PRODUCT CODE, HWK. PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE DURING 2007. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    NON UNION OF A PATIENT FEMUR WAS REPORTED. THE PATIENT WAS ORIGINALLY TREATED FOR A BROKEN FEMUR WITH A RETRO/ANTEGRADE FEMORAL FIXATION NAILING SYSTEM. THE IMPLANT DATE WAS REPORTED AS AN UNKNOWN DATE IN 2007. THE SURGEON DISCOVERED A NON-UNION DURING A ROUTINE CHECK UP ON AN UNKNOWN DATE. THE SALES CONSULTANT STATED THAT THE FEMORAL FIXATION NAILING SYSTEM WAS EXPLANTED ON (B)(6) 2013 AND THE SURGEON MAY PERFORM ADDITIONAL SURGERY AT A LATER DATE BASED ON BONE REACTION. THE EXPLANTED HARDWARE WILL NOT BE RETURNED FOR EVALUATION. THIS REPORT IS FOR ONE, 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS REPORT IS 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398147 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention