BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X360MM X 1

    MDR report key: 2798925 · Received October 11, 2012

    Report

    Report Number
    9610622-2012-00453
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: LAG SCREW, TI GAMMA3 10.5X95MM: LOT NO. K883868, CATALOG # 3060-0095S. LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM: LOT NO. K395138, CATALOG # 1896-5045S. LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM: LOT NO. K288276, CATALOG # 1896-5040S.

    Description of Event or Problem · 1

    THE SALES REP HAS BEEN INFORMED FROM THE HOSPITAL THROUGH THE SURGEON THAT THE NAIL HAS BROKEN THROUGH THE COLLUM LAG SCREW HOLE. THE PATIENT HAD SURGERY ON (B)(6) FOR REMOVAL OF NAIL AND THE CLINIC WILL PUT IN A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X360MM X 1 IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K299767

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other| R