BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 46MM

    MDR report key: 3143359 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03051
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES AND COMMON DEVICE NAMES: KTT ¿ APPLIANCE, FIXATION, NAIL; HRS ¿ PLATE, FIXATION, BONE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT¿S INITIAL SURGERY WAS PERFORMED ON (B)(6) 2009 FOR A DISTAL FEMUR FRACTURE. DURING A FOLLOW UP VISIT SURGEON NOTED DEVELOPMENT OF A NON-UNION. PATIENT DID NOT WANT TO UNDERGO REVISION SURGERY AND A BONE STIMULATOR WAS USED AS AN ALTERNATIVE. SUBSEQUENTLY, THE PLATE BROKE AND SURGEON REMOVED A 4.5MM LCP CONDYLAR PLATE AND 9 ASSORTED SCREWS DUE TO A NON-UNION ON (B)(6) 2013. PATIENT WAS IMPLANTED WITH A LONGER CONDYLAR PLATE, SCREWS, DBX BONE GRAPH AND AN ARTICULATING DEVICE. THIS IS 10 OF 10 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244739 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 46MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention