BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM BONE SCREWS, DIAM 2.0X7MM, SELF-TAPPING

    MDR report key: 1811326 · Received August 19, 2010

    Report

    Report Number
    8010177-2010-00295
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON HELD THE SCREW WITH THE DRIVER, HE FELT THE SCREW HEAD AND DRIVER LOOSE AND HARD TO PICK. HE TRIED TO PICK THE SCREW AND SCREWING, BUT THE SCREW HEAD WORN. SO, THE SURGEON USED A SPARE PRODUCT INSTEAD OF IT, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM BONE SCREWS, DIAM 2.0X7MM, SELF-TAPPING IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK