BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 2042161 · Received March 28, 2011

    Report

    Report Number
    1719045-2011-00144
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: DURING AN ANTERIOR CERVICAL FUSION LEVEL C5-C7 SURGEON WAS USING THE EXTRACTION SCREWDRIVER AND THE TIP BROKE OFF INTO A SCREW HEAD. SURGEON DID NOT REMOVE THE TIP FROM THE SCREW HEAD, IT REMAINS IN THE PATIENT ESTIMATED SIZE 1.5 MM. THE SCREW WAS BEING REMOVED TO RE-POSITION THE PLATE WHEN THE TIP OF THE DRIVER BROKE IN THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTION SCREWDRIVER EXTRACTION SCREWDRIVER HXX SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCREW