BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 12

    MDR report key: 2668699 · Received July 19, 2012

    Report

    Report Number
    9610622-2012-00309
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    April 20, 2012
    Report Date
    July 2, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) LAG SCREW, TI GAMMA3 10.5X95MM K197518, (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM K228966, (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM K291999.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 LONG NAIL. ABOUT 2 YEAR AFTER, THE SURGEON FOUND THROUGH THE X-RAY THAT THE LAG SCREW HOLE OF THE NAIL WAS BROKEN. THEREFORE THE PATIENT UNDERWENT THE REMOVING SURGERY OF THE IMPLANTS AND THE CHS REVISION SURGERY ON (B)(6) 2012. THE SURGEON REQUESTED THE INVESTIGATION OF THE REMOVED IMPLANTS. THE CALLUS WAS NOT AT THE FRACTURE PART OF PATIENT BONE. THE PATIENT WAS MOVING ACTIVELY AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K181921

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R