BEUDAMED
    FDA Adverse Event Other Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT 10X260MM X 125

    MDR report key: 1589257 · Received January 26, 2010

    Report

    Report Number
    9610622-2010-00039
    Event Type
    Other
    Date Received
    January 26, 2010
    Date of Event
    January 9, 2010
    Report Date
    January 12, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. NO DEVICE FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT THE SURGERY WITH GAMMA3 LONG NAIL BY MIDNIGHT SHIFT STAFF. AFTER THE SURGERY, THE SURGEON FOUND THAT THE WRONG SIDE NAIL WAS IMPLANTED FOR PATIENT. (PATIENT BROKEN RIGHT LEG, HOWEVER, THE SURGEON USED LEFT IMPLANT). THE SURGEON IS NOT PLANNING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT 10X260MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K197584

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other