BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY SCREW DRIVER

    MDR report key: 753659 · Received August 16, 2006

    Report

    Report Number
    9617297-2006-00001
    Event Type
    Injury
    Date Received
    August 16, 2006
    Date of Event
    June 19, 2006
    Report Date
    July 21, 2006
    Manufacturer
    U&I CORP.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON STRUGGLED WITH THE DRIVER; AS IT WAS TOO LONG TO FIT UNDERNEATH THE MICROSCOPE MAKING IT DIFFICULT TO GET THE PROPER ANGLE WHILE IMPLANTING PEDICLE SCREWS. WHILE ATTEMPTING TO GET THE CORRECT ANGLE IN ORDER TO IMPLANT THE L5-S1 SCREW ON THE PATIENT'S LEFT SIDE, THE SURGEON SLIPPED AND HIT THE DURA, CUTTING IT OPEN. THE DURA HAD TO BE SUTURED SHUT, WHICH ADDED 30 MINUTES TO THE CASE (CASE TOOK A TOTAL OF 3 HOURS). THE SURGEON THEN USED "LOOPS" TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY SCREW DRIVER SCREWDRIVER (HXX) HXX U&I CORP. SP0008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention