BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X300MM X 12

    MDR report key: 2836046 · Received November 7, 2012

    Report

    Report Number
    9610622-2012-00509
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 3065-0100S U-BLADE SET, TI GAMMA3 10.5X100MM, LOT# K286481; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40MM, LOT# K794599; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40MM, LOT# K115812.

    Description of Event or Problem · 1

    ON (B)(6) 2012 GAMMA3 LONG NAIL EXTRACTION WAS PERFORMED. THE NAIL BROKE AFTER 6 MONTHS FROM PRIMARY SURGERY. THE FRACTURE WAS NOT FUSION COMPLETELY YET. THE PT UNDERWENT THE PRIMARY SURGERY OF OTHER COMPANY NAIL ON (B)(6) 2011. AFTER THAT BONE FUSION WAS NOT CARRIED OUT AND REFRACTURE WAS CONFIRMED ON THE PART OF DISTAL SCREW. THEN ON (B)(6) 2012 THE PT UNDERWENT THE REVISION BY GAMMA3 LONG NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X300MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K878377

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R