BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1

    MDR report key: 2850943 · Received November 20, 2012

    Report

    Report Number
    9610622-2012-00537
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 12, 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 ADD¿L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD¿L DEVICES: 3060-0110S LAG SCREW, TI GAMMA3 - 10.5X110MM K907101, 1896-5055S LOCKING SCREW, FULLY THREADED T2 TIBIA - 5X55 MM LOT # K923189, 1896-5050S LOCKING SCREW, FULLY THREADED T2 TIBIA - 5X50MM LOT # K959948, 3005-1100S END CAP, STD, TI GAMMA3 LOT # K569985, 3003-0822S SET SCREW, TI GAMMA3 - 8X17.5MM LOT # K272840.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K272840

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R