BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1

    MDR report key: 2722224 · Received August 28, 2012

    Report

    Report Number
    9610622-2012-00386
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    June 11, 2010
    Report Date
    August 9, 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

    DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE RETURNED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: LAG SCREW, TI GAMMA 10.5X85MM, 3060-0085S, K208233 LOT NO; LOCKING SCREW, FULLY THREADED TW TIBIA 5X40 MM, K776670 LOT NO; LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40MM, 1896-5040S, K253096 LOT NO.

    Description of Event or Problem · 1

    ON (B)(6) 2010, G3 LONG NAIL OPERATION WAS PERFORMED. NINE DAYS AFTER THE OPERATION, THE PATIENT SUFFERED A FRACTURE AGAIN AT THE PART OF NAIL'S END. ALTHOUGH THE NAIL WAS REPLACED TO MORE LONG NAIL, THE PATIENT SUFFERED A FRACTURE AGAIN AT THE PART OF THE DISTAL SCREW. THE SURGEON CHOSE THE CONSERVATIVE TREATMENT AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K193816

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention