BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM

    MDR report key: 1963855 · Received December 22, 2010

    Report

    Report Number
    8010177-2010-00477
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER CUSTOMER, SURGEON WAS TIGHTENING A SCREW AND IT BROKE OFF IN PATIENT'S HEAD WHEN ABOUT HALF WAY TIGHTENED. THEY WERE ABLE TO REMOVE THE REST OF THE SCREW. THE REPLACEMENT SCREW WAS BEING TIGHTENED AND THE HEAD BROKE OFF AGAIN. THEY WERE NOT ABLE TO RECOVER THE REST OF SCREW ON THIS ONE AND HAD TO LEAVE IT IN THE PATIENT. THE PROCEDURE WAS A ZMC AND FLOOR REPAIR. PER SALES REP, ALL PRODUCTS BEING USED WERE STRYKER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK