BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED 5X50 MM

    MDR report key: 1837624 · Received September 14, 2010

    Report

    Report Number
    9610622-2010-00376
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K010801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    A NURSE FROM (B)(6). REPORTED BY E-MAIL, ON (B)(6) 2010, PATIENT UNDERWENT SURGICAL FOR A FRACTURED FEMUR. A GAMMA3 LONG NAIL WAS IMPLANTED ON (B)(6). THE PATIENT UNDERWENT AN UNANTICIPATED REVISION SURGERY, BECAUSE OF AN ISSUE OF INTRA-ROTATION OF THE KNEE. DURING THE SURGICAL PROCEDURE, TWO DISTAL SCREWS WERE REMOVED, EXTRA-ROTATION OF THE GAMMA3 LONG NAIL. AFTER THE ALIGNMENT OF THE FEMUR WITH EXTRA-ROTATION OF THE LIMB, THE SURGEON REPLACED THE TWO SCREWS WITH CAT 1896-5050S, LOT K295621, K189255. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE NAIL IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X50 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K295621/K189255

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention