BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1914515 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01539
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE REPORTED EVENT, THIS EVENT ATTRIBUTED TO THE USER MISHANDLING. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLANNED TO RECEIVE A CERVICAL PROCEDURE USING THE GUIDE WIRES. DURING THE SURGERY IT WAS FOUND THAT THE GUIDE WIRE THAT WERE BEING USED TO TREAT THE PATIENT WAS NOT STERILIZED. REPORTEDLY, THE OPENED SURGICAL SITE HAD TO BE CLEANED UP AND THE SURGICAL PROCEDURE HAD TO BE SUSPENDED. 17 DAYS POST THE EVENT THE CERVICAL PROCEDURE WAS RESUMED AND WAS SUCCESSFULLY PERFORMED. NO FURTHER INCIDENT INCLUDING INFECTION WAS REPORTED. THE PATIENT WAS DOING WELL POST THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 Hospitalization| R