BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS RAD ROD 6.0 X 40 MM

    MDR report key: 2103664 · Received May 20, 2011

    Report

    Report Number
    9617544-2011-00181
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    February 2, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW. RESULT: COMPLAINT HISTORY REVIEW REVEALED THAT THIS IS THE 3RD COMPLAINT OF THIS NATURE RECEIVED ON THE MANTIS PRODUCT RANGE SINCE IT WAS 1ST LAUNCHED IN 2006. CONCLUSION: A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AS THE COMPLAINT SAMPLES WERE NOT AVAILABLE FOR EVALUATION AND THE BATCH NUMBERS OF THE IMPLICATED PRODUCT WERE NOT SUPPLIED. HOWEVER, X-RAYS WERE RECEIVED OF POST-IMPLANTATION, PRE-REVISION AND POST-REVISION. THE DETACHED ROD CAN BE CLEARLY SEEN IN THE PRE-REVISION X-RAY, WHICH WAS TAKEN APPROX 2 WEEKS AFTER THE INITIAL SURGERY. THE SCREWS HAVE REMAINED FIXED IN POSITION. (B)(4) REPORTED THAT THE BLOCKER OF THE RIGHT SCREW IN T11 WAS FOUND INSIDE THE SCREW-HEAD (FOLLOWING ROD DISENGAGEMENT), BUT IT WAS NO LONGER IN THE THREADS, ONLY LYING ON THE TOP OF THE HEAD. ALL THE OTHER BLOCKERS WERE LOOSE, BUT THEY WERE INSIDE THE SCREW-HEADS AND THE THREAD. THE MOST PROBABLE CAUSE FOR THE FAILURE IS INSUFFICIENT BLOCKER TIGHTENING, I.E. THE XIA BLOCKERS WERE NOT TIGHTENED TO 12NM BY THE SURGEON, IN-ERROR, DESPITE INSTRUCTIONS TO THIS EFFECT IN THE MANTIS SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    DR. (B)(6), SENIOR PHYSICIAN OF THE HOSPITAL, REPORTED TO OUR SALESREP (B)(4), THAT A PT CAME IN WITH PAIN. SHE TOOK AN X-RAY AND SAW THAT A REVISION SURGERY RELATED TO LOOSEN RODS WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS RAD ROD 6.0 X 40 MM IMPLANT MNH STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR