BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND DIAMOND AM-33D

    MDR report key: 369889 · Received January 2, 2002

    Report

    Report Number
    1625507-2001-00868
    Event Type
    Injury
    Date Received
    January 2, 2002
    Report Date
    December 6, 2001
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE HAS BEEN USING THE MIDAS REX SYSTEM ON A WEEKLY BASIS SINCE 1994. ON A LETTER SENT TO MIDAS REX HE STATED: "I HAD A VERY UNFORTUNATE INCIDENT WHEN THE 33D DISSECTING TIP SLIPPED AND INJURED NERVES DURING DECORTICATING POSTERIOR PROCEDURE ON A LUMBAR SPINE. MAY I ASK CONFIRMATION FROM YOUR OFFICE THAT DECORTICATION IN LUMBAR SPINE FUSION IS IN FACT A PROCEDURE INDICATED FOR THE MIDAS REX AND THE DISSECTER 33D USED IS ALSO INDICATED?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND DIAMOND AM-33D SURGICAL DISSECTING TOOL HBB MEDTRONIC MIDAS REX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN