BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 7.5 X 55 MM

    MDR report key: 2230831 · Received August 23, 2011

    Report

    Report Number
    9617544-2011-00289
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 25, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO 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

    DOC (B)(6), HEAD PHYSICIAN OF THE HOSPITAL, REPORTED TO OUR SALES REP (B)(6) THAT HE WAS PERFORMING A SURGERY. DURING THIS,HE USED THE MANTIS CANNULATED POLYAXIAL SCREW. HE OBSERVED, AFTER A LONG TIME, THAT THE CONNECTING LINK ON THE SIDE WAS BROKEN, BECAUSE HE WAS NOT ABLE TO FIX THE BLADE. HE CHANGED THE MANTIS CAN. POL. SCREW AND REMOVED ALL PARTS OF THE FIRST SCREW. THE SURGEON COMPLETED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED POLYAXIAL SCREW 7.5 X 55 MM IMPLANT MNH STRYKER SPINE BORDEAUX NA 09E304

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention