BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERAL NAIL LONG, LEFT 8X220 MM

    MDR report key: 1770194 · Received July 21, 2010

    Report

    Report Number
    9610622-2010-00303
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043404
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. NO EVALUATION WILL BE PERFORMED. IF RELEVANT INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B) (6)2010, THE PT UNDERWENT SURGERY WITH THE T2 PH LONG NAIL. ON (B) (6)2010, THE SURGEON FOUND BY X-RAY, THAT THE DISTAL SCREW BACKED OUT OF THE NAIL. THE SURGEON TOOK X-RAYS EVERY WEEK AND TO MONITOR THE PT. HOWEVER, THE DISTAL SCREW WAS REMOVED BECAUSE THE PT HAD PAIN, AND THE SCREW WAS REPLACED. THE SURGEON DRILLED TWICE IN THE SAME SCREW HOLE BECAUSE THE SCREW MADE CONTACT WITH NAIL WHEN DISTAL SCREW WAS INSERTED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMAL HUMERAL NAIL LONG, LEFT 8X220 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention