BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSPIRE

    MDR report key: 2584469 · Received May 21, 2012

    Report

    Report Number
    3007289746-2012-00001
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    SPINE VIEW INC.
    Product Code
    HRX
    PMA / PMN Number
    K110992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW UP VISIT TO THE SURGERY CENTER, SPINE VIEW SALES REPRESENTATIVE WAS OBSERVING ANOTHER CASE WITH THE SURGEON AND WAS ABLE TO ESTABLISH THAT THE SURGEON MAY HAVE POSSIBLY REPOSITIONED THE CANNULA WITHOUT REMOVING THE DEVICE FROM THE CANNULA. IN SO DOING, THERE IS A HIGH POSSIBILITY OF DAMAGE THAT CAN LEAD TO BREAKAGE OF THE DEVICE. THE IFU STATES "IF ADDITIONAL TREATMENT IS REQUIRED WITHIN THE DISC, REINSERT THE STRAIGHT STYLET INTO THE CANNULA AND REPOSITION THE CANNULA."

    Description of Event or Problem · 1

    THE SURGEON WAS REPORTED TO HAVE BEEN IN A CASE INVOLVING L3-L4, L4-L5, L5-S1 PERCUTANEOUS DISCECTOMY ON A (B)(6) MALE PATIENT. THE SURGEON HAD A PROBLEM PLACING THE NEEDLE AT L3-L4 DUE TO OSTEOPOROSIS AND BONE GROWTH, THEREFORE HE MOVED ON TO L4-L5. HE EXPERIENCED SOME PROBLEMS IN THIS LEVEL AS WELL. HE WAS ABLE TO GET A GOOD AP X-RAY, BUT STATED THAT HE DID NOT NEED A LATERAL BECAUSE IT WAS TOO DIFFICULT TO GET A GOOD IMAGE. THE DOCTOR PROCEEDED TO PERFORM THE DISCECTOMY. AFTER A FEW SECONDS, THE DEVICE STOPPED WORKING ALL TOGETHER. THE DISTRIBUTOR PRESENT IN THE CASE ADVISED THE SURGEON THAT HE MAY NOT BE IN THE DISC SPACE AND THAT HE WAS PROBABLY HITTING BONE CAUSING THE DEVICE TO STOP WORKING. A LATERAL WAS TAKEN AT THIS POINT. THE LATERAL SHOWED THAT THE NEEDLE WAS NOT ADVANCED ENOUGH INTO THE DISC. DR. (B)(6) TRIED TO ADVANCE IT FURTHER BUT WAS UNSUCCESSFUL. HE STATED THAT THE NEEDLE COULD NOT ADVANCE ANYMORE. HE RAN THE DEVICE AGAIN BUT IT STOPPED WORKING AGAIN. DR. (B)(6) DECIDED HE HAD TAKEN ENOUGH OUT OF THE DISC AND PROCEEDED TO PULL OUT THE DEVICE WITHOUT RETRACTING THE EXPANDABLE SPIRAL WIRE. AS THE SCRUB NURSE WAS REMOVING THE DISC MATERIAL FROM THE COLLECTION CHAMBER, SHE RETRACTED THE SPIRAL WIRE AND ADVANCED THE DEVICE IN THE CANNULA. IT WAS AT THIS TIME THAT THEY NOTICED THAT THE TIP OF THE DEVICE HAD BROKEN OFF. THE DOCTOR WAS INFORMED IMMEDIATELY AND HE TOOK AN X-RAY AND THERE APPEARED TO BE A SMALL BLACK SPOT ON THE X-RAY THAT MAY NOT HAVE BEEN SEEN IN PRIOR IMAGES. THE SURGEON THEN PROCEEDED TO L5-S1 USING A NEW DEVICE. HE DID A MINOR DISCECTOMY AND THEN STATED THAT HE WAS FINISHED. AFTER THE SURGERY, DR. (B)(6) THOUGHT THAT THE BROKEN TIP WAS A MISTAKE THAT RESULTED FROM PULLING THE DEVICE WITHOUT RETRACTING THE EXPANDED SPIRAL WIRE. AT THAT TIME HE ALLUDED TO A FUTURE FOLLOW UP ON THE BROKEN PIECE WITH PATIENT BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSPIRE DEBRIDER HRX SPINE VIEW INC. 20111110-02FG

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other