BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM

    MDR report key: 3110606 · Received May 14, 2013

    Report

    Report Number
    0009617544-2013-00185
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION;DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW. RESULT: VISUAL: THE DEVICE FAILURE IS CONFIRMED UPON VISUAL INSPECTION OF THE DEVICE. THE BREAKAGE OCCURRED IN THE MID PORTION OF THE BODY OF THE SCREW, APPROXIMATELY 18MM FROM THE SCREW-HEAD (MEASURED FROM START OF THE SCREW BODY THREADING TO THE START OF THE FRACTURE SURFACE). THE FRACTURE SURFACE IS PERPENDICULAR TO THE LONG AXIS OF THE SCREW BODY. THE FRACTURE TAKES PLACE OVER A SINGLE ROTATION OF THE SCREW, I.E. THE FRACTURE SURFACE FOLLOWS THE SPIRAL THREADING FOR ONE ROTATION. A CLOSER LOOK INSPECTION OF THE FRACTURE SURFACE INDICATES ARC-LIKE STRIATIONS SIMILAR TO BEACH MARKS THAT SUGGEST THE DIRECTION OF PROPAGATION IN A FATIGUE-LIKE MANNER. A REVIEW OF THE COMPLIANT HISTORY INDICATED THAT THE MAJORITY OF COMPLAINTS SUGGEST CONTRAINDICATIONS SUCH AS OBESITY OR PATIENT ACTIVITY LEVEL AS THE CAUSE OF THE POST-OPERATIVE SCREW BREAKAGE, BUT THE FUNDAMENTAL CAUSE IS OFTEN UNKNOWN BECAUSE THE FAILURE IS DISCOVERED ONLY BY X-RAY AFTER THE BREAKAGE HAS ALREADY OCCURRED. CONCLUSION: THE SCREW BREAKAGE (FRACTURE WITHIN THE BULK OF THE SCREW BODY) WAS CONFIRMED UPON VISUAL INSPECTION. THE BREAKAGE OCCURRED POST-OPERATIVELY AND REQUIRED A REVISION SURGERY. THE FAILURE WAS MOST LIKELY CAUSE BY PSEUDOARTHROSIS AS INDICATED BY THE SURGEON WHO PERFORMED THE REVISION. AN INSPECTION OF THE IMPLANT FRACTURE SURFACE STRONGLY SUGGESTS A FATIGUE-LIKE MANNER, WHICH IS ALSO CONSISTENT WITH THE FAILED FUSION INDICATED BY PSEUDOARTHROSIS. THE MANUFACTURING RECORD FOR LOT # 082505 WAS REVIEWED AND THERE WERE NO RELEVANT NONCONFORMANCES REPORTED. AS INDICATED IN THE IFU, THE DEVICE CANNOT REPLICATE THE STRENGTH AND FLEXIBILITY OF NORMAL BONE AND CAN BREAK AS A RESULT OF REPETITIVE/EXCESSIVE STRESSES DURING THE COURSE OF THE ACTIVE LIFESPAN OF THE DEVICE IF FUSION DOES NOT OCCUR. THE IFU ALSO ADDRESSES CONTRAINDICATIONS, CONDITIONS OF USE, PATIENT LIMITATIONS, IMPLICATIONS OF IMPLANT SELECTION, AND ADVERSE EFFECTS RELEVANT TO POST-OPERATIVE IMPLANT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UPON REMOVAL OF MANTIS SCREWS, THE RIGHT SIDE S1 SCREW WAS FOUND TO BE BROKEN. I AM RETURNING THE SCREWS. THIS BREAK WAS NOT NOTICED UNTIL THE REMOVAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UPON REMOVAL OF MANTIS SCREWS, THE RIGHT SIDE S1 SCREW WAS FOUND TO BE BROKEN. I AM RETURNING THE SCREWS. THIS BREAK WAS NOT NOTICED UNTIL THE REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211763 MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM MNH STRYKER SPINE-FRANCE 082505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention