BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLE MAKER M-18H

    MDR report key: 321213 · Received February 28, 2001

    Report

    Report Number
    1625507-2001-00551
    Event Type
    Other
    Date Received
    February 28, 2001
    Report Date
    August 9, 1999
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON STATED HE HAD A PT EXPERIENCE SOME DEGREE OF PARALYSIS FOLLOWING A FUSION. THE SURGEON USED NEW SPINE INSTRUMENTATION AND WOULD LIKE TO KNOW IF THERE ARE ANY REPORTED PROBLEMS WITH MIDAS TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8127 HOLE MAKER M-18H SURGICAL DISSECTING TOOL HBE MEDTRONIC MIDAS REX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other