BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 1.5X5

    MDR report key: 2201646 · Received August 4, 2011

    Report

    Report Number
    8010177-2011-00225
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K031659
    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 PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    WHILE TIGHTENING THE SCREW, THE HEAD SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 1.5X5 IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK