BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAPERED 9TA30

    MDR report key: 457713 · Received May 2, 2003

    Report

    Report Number
    1625507-2003-00114
    Event Type
    Other
    Date Received
    May 2, 2003
    Date of Event
    March 25, 2003
    Report Date
    March 25, 2003
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURA WAS TORN DURING SPINAL PROCEDURE WHILE USING 9TA30 DISSECTING TOOL IN AF03 ATTACHMENT. THIS REPORT WAS INITIATED BY A TECHNICAL SERVICE CALL REGARDING THE CORRECT TOOL SELECTION FOR USE WITH THE AF03 ATTACHMENT. ON FOLLOW UP, IT WAS REPORTED THAT THE DURA WAS REPAIRED DURING THE INITIAL PROCEDURE, WITH NO KNOWN PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED 9TA30 SURGICAL DISSECTING TOOL LEGEND HBE MEDTRONIC MIDAS REX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention