BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1650120 · Received March 31, 2010

    Report

    Report Number
    1030489-2010-00435
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THIS IS A LIKE/SIMILAR PRODUCT TO (B) (4), 510(K) NUMBER K052261. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTER BROKE DURING A CAGE INSERTION. THE FORCE OF THE BREAK CAUSED THE SURGEON TO "SLAM" INTO THE PATIENT'S DURA AND NERVE ROOT THUS CAUSING A TEAR. SURGERY TIME WAS EXTENDED APPROXIMATELY 45 MINUTES. CURRENTLY, THE PATIENT SHOWS NO SIGNS OF PAIN, OTHER SYMPTOMS, OR ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT INSERTER LXH MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention