BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 7.5 X 40 MM

    MDR report key: 2894500 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00600
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "MANTIS SCREW TULIP TORE BY FORCE FROM PERSUADER WHILE REDUCING A ROD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED POLYAXIAL SCREW 7.5 X 40 MM IMPLANT MNH STRYKER SPINE BORDEAUX NA 0000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK