BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X400MM X 1

    MDR report key: 2839047 · Received November 13, 2012

    Report

    Report Number
    9610622-2012-00525
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: (B)(4) LAG SCREW, TI GAMMA3 10.5X100MM, LOT# K913828.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVIEWED X-RAYS AND DETERMINED THE GAMMA NAIL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X400MM X 1 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K390821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R