BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM

    MDR report key: 2081064 · Received April 14, 2011

    Report

    Report Number
    9617544-2011-00137
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K061813
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    SETTING: 4X MANTIS SCREWS ALL IN PATIENT, LOADED WITH SIZE 2 BLADES AND SLIP RINGS, ROD SEATED. CAP INSERTED AT ONE END AND TIGHTENED (NOT TORQUED). BLOCKER AT OTHER END NOT IN SITU. ACTION: PERSUADER INSERTED TO LOAD OTHER BLOCKER. PERSUADER APPEARED TO BE SLIGHTLY OFF CENTRE. SURGICAL ASSISTANT USED PERSUADER RAPIDLY WITH LOTS OF FORCE CAUSING THE BLADE MOUNTING BRACKETS ON THE SCREW TO SNAP AND THE BLADES TO LIFT OFF THE SCREW. RESULT:....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA 10G051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK