BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS COMPRESSION AND DISTRACTION SHAFT

    MDR report key: 2130478 · Received June 13, 2011

    Report

    Report Number
    9617544-2011-00200
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL TESTING. RESULT: THE RETURNED MANTIS COMPRESSION & DISTRACTION SHAFT AND MANTIS REDUCTION BLADES WERE VISUALLY INSPECTED BUT NO DEFECTS WERE OBSERVED. THE RETURNED PRODUCTS WERE FOUND TO BE FUNCTIONALLY COMPLIANT. CONCLUSION: THE MANTIS REDUCTION BLADES ARE DESIGNED FOR PERCUTANEOUS USE. THE MANTIS COMPRESSION & DISTRACTION SHAFT IS DESIGNED FOR USE WITH THE SCREW-BLADE ASSEMBLY. THE INSTRUMENTS WERE NOT USED AS INTENDED / DESIGNED THUS EXPLAINING THE REPORTED FAILURES. THE MANTIS SURGICAL TECHNIQUE CLEARLY STATES THAT THE MANTIS SPINAL SYSTEM IS INTENDED FOR PERCUTANEOUS USE AND THE SURGEON SHOULD BE THOROUGHLY FAMILIAR WITH THE SURGICAL PROCEDURE, INSTRUMENTS AND IMPLANT CHARACTERISTICS PRIOR TO PERFORMING THE SURGERY.

    Description of Event or Problem · 1

    THE SALES REP REPORTED VIA THE PHONE THAT THE SURGEON WAS PERFORMING SPINE SURGERY WITH THE LOAN KIT "MANTIS" (B)(4) WHICH IS DESIGNED TO BE USED FOR MINIMALLY INVASIVE SURGERY. HE REPORTED THAT DUE TO THE FACT THAT THE SURGEON FELT UNEXPERIENCED WITH THIS PARTICULAR KIT, THE SURGEON DECIDED TO PERFORM THE SURGERY AS AN OPEN PROCEDURE. HE FURTHER REPORTED THAT THE "BLADES" THAT ARE TO BE FOUND ON TOP OF THE SCREWS (WHOSE FUNCTION IS TO KEEP SOFT TISSUE OUT OF THE WAY AND, AS THIS WAS AN OPEN PROCEDURE, WERE NOT PERFORMING ANY FUNCTION IN THIS CASE FROM THE SALES REP'S POINT OF VIEW) POPPED OFF. HE ADDED THAT BECAUSE OF THIS, THE SURGEON TOOK THEM OFF AND COMPRESSED THE SCREWS WITH TWO COMPRESSION RODS. HE ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS COMPRESSION AND DISTRACTION SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 107132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other