BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12

    MDR report key: 2777586 · Received October 1, 2012

    Report

    Report Number
    9610622-2012-00446
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 20, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: (B)(4) LAG SCREW, TI GAMMA3 10.5X100MM, LOT # K559374. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM, LOT#K276864. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM, LOT# K841599.

    Description of Event or Problem · 1

    IMPLANT SURGEON OF THE HOSPITAL REPORTED TO OUR SALES REP THAT A PATIENT CAME IN WITH PAIN. HE TOOK SOME X-RAYS AND OBSERVED THAT THE NAIL WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K666262

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other| R