BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREWS WITH T25 STARDRIVE RECESS

    MDR report key: 3223020 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04404
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE EXACT CATALOG NUMBER IS UNKNOWN FOR 2 SCREWS. THIS REPORT IS FOR 2 SCREWS THAT BELONG TO THE PART FAMILY 04.005.5XX. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A CATALOG NUMBER AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON (B)(6) 2010 WITH LATERAL ENTRY NAIL, END CAP AND 4 SCREWS (2 PROXIMAL SCREWS AND 2 DISTAL SCREWS) FOR A SEGMENTAL LEFT FEMUR FRACTURE. PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE 2 PROXIMAL SCREWS FOR UNKNOWN REASONS ON AN UNKNOWN DATE. REPORTEDLY, THE FRACTURE HAD HEALED. PATIENT COMPLAINED OF IRRITATION FROM THE 2 DISTAL SCREWS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO REMOVE THE 2 DISTAL SCREWS. THE NAIL AND END CAP WERE ALSO REMOVED. THERE WERE NO REPORTED ISSUES WITH THE NAIL OR END CAP. SURGERY REPORTEDLY WENT WELL WITH NO COMPLICATIONS. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322058 5.0MM TI LOCKING SCREWS WITH T25 STARDRIVE RECESS HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention