BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CORTEX SCREW SELF-TAPPING 44MM

    MDR report key: 1050311 · Received May 22, 2008

    Report

    Report Number
    1719045-2008-00072
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 30, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PRE-76
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURING DATE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE THREADS OF THE 4.0 MM CORTEX SCREW STRIPPED DURING INSERTION, PARALLEL TO AND NOT IN CONTACT WITH OTHER HARDWARE. SURGEON NOTED THREAD FRAGMENT ON A POST OP X-RAY AND PERFORMED REMOVAL OF THREAD FRAGMENT BUT LET THE SCREW IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM CORTEX SCREW SELF-TAPPING 44MM COTEX SCREWS SELF TAPPING HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention