BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRX

    MDR report key: 3232749 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03061
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 29, 2013
    Report Date
    October 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED. ANALYSIS IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. SUBMITTED PICTURE APPEARS TO SHOW MICROPITUITARY HAS NO DAMAGE OR DEFECT THAT CAN BE IDENTIFIED FROM THE SUBMITTED IMAGES. NO ADDITIONAL INFORMATION ABOUT THE EVENT CAN BE DETERMINED FROM THE SUBMITTED PICTURES. PRODUCT NOT RETURNED. UNABLE TO PHYSICALLY EXAMINE PRODUCT AND PROVIDE ADDITIONAL ANALYSIS. UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR MICRO ENDOSCOPIC DISCECTOMY TO TREAT LUMBAR DISC HERNIATION AT L4-L5. DURING REMOVAL OF THE HERNIA AT L4-5, THE DURA WAS DAMAGED. IN ADDITION, CAUDA EQUINA SEEMED TO BE CUT ACCORDING TO THE SURGEON. THE SURGEON FIXED THE DURA USING SUTURE AND SURGICAL GLUE. POST-OP, IT WAS CONFIRMED THAT THE PATIENT HAD MOBILITY IN HIS LE. FURTHER COMPLICATION IS UNKNOWN. THE SURGEON COMMENTED THAT THE CAUSE OF THE INCIDENT WAS A HUMAN ERROR. THE SURGERY TIME WAS EXTENDED FOR MORE THAN AN HOUR DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333505 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ05C068

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention