BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS REDUX BLOCKER

    MDR report key: 3033499 · Received April 3, 2013

    Report

    Report Number
    0009617544-2013-00116
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K092631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, VISUAL INSPECTION AND RISK ASSESSMENT. RESULT: A THOROUGH INVESTIGATION OF THE BLOCKER WAS NOT POSSIBLE BECAUSE THE DEVICE IS UNAVAILABLE. NEVERTHELESS EVIDENCE OF MISUSE WAS INDICATED AS A RESULT OF NOT USING THE COUNTER TORQUE TUBE. THE COUNTER TORQUE TUBE IS ESSENTIAL TO THE FINAL TIGHTENING PROCESS BECAUSE IT ENSURES PROPER ENGAGEMENT OF THE BLOCKER WITHIN THE TULIP. THE BLOCKER FAILURE (BLOCKER LOOSENING LEADING TO CONSTRUCT DISENGAGEMENT) WAS CONFIRMED VIA X-RAY AND REVISION SURGERY WAS REQUIRED. COMPLAINT RECORDS WERE REVIEWED FROM MARCH 2004 TO AUGUST 8, 2013; THE MAJORITY OF THE CORRESPONDING INVESTIGATIONS INDICATED INSUFFICIENT BLOCKER TIGHTENING AS THE MOST LIKELY CAUSE OF POST-OPERATIVE DISENGAGEMENT. IF ANY ADDITIONAL INFORMATION COULD BE OBTAINED, THE COMPLAINT CAN BE REOPENED AND REEVALUATED. CONCLUSION: AS THE DEVICE WAS NOT RETURNED A DEFINITE CONCLUSION CANNOT BE STATED. HOWEVER, THE MOST PROBABLE CAUSE FOR THE FAILURE IS INSUFFICIENT BLOCKER TIGHTENING I.E. THE XIA BLOCKERS WERE NOT TIGHTENED TO 12NM BY THE SURGEON, DESPITE INSTRUCTIONS TO THIS EFFECT IN THE MANTIS SURGICAL TECHNIQUE GUIDE.

    Additional Manufacturer Narrative · 1

    HOSPITAL IS NOT ALLOWING RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SET SCREW DISENGAGED FROM TULIP ON MANTIS REDUX SYSTEM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SET SCREW DISENGAGED FROM TULIP ON MANTIS REDUX SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136579 MANTIS REDUX BLOCKER LITE BLOCKER - CLOSURE COMPONENT MNH STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R