BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MMX12

    MDR report key: 2832989 · Received October 30, 2012

    Report

    Report Number
    9610622-2012-00485
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICES: 3060-0095S LAG SCREW, TI GAMMA3 10.5X95MM LOT # K648129, 3060-0100S LAG SCREW, TI GAMMA3 ?10.5X100MM LOT# K390385.

    Description of Event or Problem · 1

    THE NURSE REPORTED TO OUR SALES REP THAT A PT CAME IN WITH PAIN. X-RAYS WERE TAKEN AND IT WAS OBSERVED THAT THE NAIL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MMX12 IMPLANT HSB STRYKER TRAUMA GMBH NA K231003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R