BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARDRIVE SCREWDRIVER SHAFT

    MDR report key: 2023856 · Received March 14, 2011

    Report

    Report Number
    8030965-2011-00081
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT HAS BEEN RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM OBERDORF INDICATES DURING A SURGERY SURGEON WAS USING THE STARDRIVE SCREWDRIVER SHAFT T15 TO TIGHTEN A SETSCREW OF A TRANSCONNECTOR WHEN THE DRIVE SLIPPED FROM THE SCREW AND THE SPINAL CORD SUSTAINED INJURY. PATIENT HAS PARALYSIS OF THE RIGHT ARM AND SLIGHT PARALYSIS OF THE LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SETSCREW