BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED 5X55 MM

    MDR report key: 1855142 · Received September 30, 2010

    Report

    Report Number
    9610622-2010-00423
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    July 17, 2010
    Report Date
    September 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVAL. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT AS MDR 9610622-2010-00422 AND MDR 9610622-2010-00424. ADDITIONAL LOCKING SCREWS LISTED IN THE EVENT ARE: 1896-5045S LOT K180650, 1896-5035S LOT K177485. IT IS KNOWN WHICH IF ANY CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A SURGEON REPORTED THROUGH OUR SALES REP, A PT UNDERWENT A SURGICAL PROCEDURE DUE TO A BIFOCAL TIBIAL FRACTURE ON (B)(6) 2010 IN WHICH A T2 NAIL WAS IMPLANTED. PT WAS REVISED ON THE (B)(6) 2010. THE NAIL WAS FRACTURED NEAR THE PROXIMAL SCREW, AND WAS PRECEDED BY THE BREAKAGE OF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X55 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K857276

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention