BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI ?11X200MM X 130?

    MDR report key: 1780810 · Received July 27, 2010

    Report

    Report Number
    9610622-2010-00318
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 4, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MDR NUMBER HAS BEEN CHANGED FROM 9610622-2010-00308 TO 9610622-2010-00318. SAME PT AS MDR 9610622-2010-00319.

    Description of Event or Problem · 1

    HEAD SURGEON REPORTED IN HIS LETTER THAT THE NAIL WAS IMPLANTED ON (B)(6), 2010. ON (B)(6), 2010, FIRST TIME RADIOLOGY SHOWED VISIBLE BREAKAGE OF A SCREW. AFTER DETERIORATION OF SYMPTOMS, ON (B)(6), 2010 PROXIMAL BREAKAGE OF THE NAIL WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI ?11X200MM X 130? IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K181961

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention