BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125

    MDR report key: 2801455 · Received October 17, 2012

    Report

    Report Number
    9610622-2012-00464
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 16, 2012
    Report Date
    October 1, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE (B)(4) LAG SCREW, TI GAMMA3 10.5X105MM, LOT NO. K753653, (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM, LOT NO. K239201, (B)(4) SET SCREW, TI GAMMA3 8X17.5MM LOT NO. K114368.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FAX THAT A PT CAME IN WITH PAIN AFTER A SLIGHT FALL. IT WAS OBSERVED THAT THE NAIL WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K114368

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R