BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSPIRE FLEX MIS SURGICAL DISCECTOMY SYSTEM

    MDR report key: 2853063 · Received August 15, 2012

    Report

    Report Number
    3007289746-2012-00003
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 17, 2012
    Manufacturer
    SPINE VIEW INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF BATCH RECORDS SHOW THAT THE DEVICE MET ALL RELEASE CRITERIA. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION DURING USE. THE USER FACILITY STAFF DID NOT RETAIN THE DEVICE FOR FURTHER ANALYSIS, SO FULL EVALUATION OF THE DEVICE WAS NOT POSSIBLE. IN OUR OPINION IT IS POSSIBLE THE ANNULUS MAY HAVE BEEN BREACHED DUE TO AN EXIT POINT NOTED ANTERIOR TO THE ANNULUS BY THE SURGEON. HOWEVER, WE ARE NOT ABLE TO ASCERTAIN HOW THIS EVENT HAPPENED BASED ON THE INFORMATION CURRENTLY AVAILABLE. BUT, THERE DOES NOT APPEAR TO BE A DEVICE FAILURE. THE PROBLEM IS MOST LIKELY A RESULT OF BREACHING THE ANTERIOR ANNULUS. THE IFU CAUTIONS AGAINST BREACHING THE ANTERIOR ANNULUS.

    Description of Event or Problem · 1

    THIS WAS THE SECOND CASE PERFORMED BY THE SURGEON USING AN ENSPIRE DEVICE. THE PATIENT WAS A (B)(6) FEMALE WHO WAS UNDERGOING A TLIF PROCEDURE ON L4-L5. THE SURGEON USED AN ENSPIRE FLEX MIS DEVICE IN STRAIGHT CONFIGURATION FOR ABOUT 1 MINUTE, FOLLOWED BY 30 SECONDS OF CURVED CONFIGURATION AND THEN STOPPED, PULLED OUT THE DEVICE TO CHECK THE DISC WITH A CURETTE THEN PUT THE DEVICE BACK TO GET THE CONTRALATERAL SIDE OF THE DISC. AFTER ABOUT 30 SECONDS OF OPERATION, THE ANESTHESIOLOGIST NOTIFIED THE SURGEON THAT THE BLOOD PRESSURE OF THE PATIENT HAD DROPPED. THE DROP IN BLOOD PRESSURE WAS ATTRIBUTED TO A VASCULAR TEAR IN THE ILIAC ARTERY AND VEIN. THE SPINE VIEW REPRESENTATIVE PRESENT IN THE CASE NOTED THAT HE DID NOT SEE ANY JERKY MOTION AND THAT THE DEVICE APPEARED TO BE FUNCTIONING PROPERLY. HE ALSO NOTED THAT THE DEVICE WAS NOT INSERTED PAST 30MM INSIDE THE DISC. THE SURGERY WAS HALTED AT THIS POINT AND THE PATIENT WAS FLIPPED OVER TO ADDRESS THE VESSEL TEAR ISSUE. A GENERAL SURGEON WAS BROUGHT IN AND PROCEEDED TO REPAIR THE TORN VESSELS. THE PATIENT WAS STABILIZED AND WAS SENT TO ICU TO RECOVER. THE TLIF PROCEDURE WAS TO BE COMPLETED AFTER PATIENT RECOVERED FROM THE VESSEL REPAIR. THE DEVICE WAS DISCARDED IMMEDIATELY BY THE USER FACILITY AND WAS NOT AVAILABLE FOR FURTHER EVALUATION BY SPINE VIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSPIRE FLEX MIS SURGICAL DISCECTOMY SYSTEM DEBRIDER, PRODUCT CODE: HRX HRX SPINE VIEW INC. NA 20120529-1FG

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R