BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS REDUCTION BLADES SIZE 2

    MDR report key: 2891394 · Received December 21, 2012

    Report

    Report Number
    9617544-2012-00591
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING CLOSING AND CLEAN UP, IT WAS DETERMINED THAT THE TAB PORTION OF A BLADE WAS BROKEN OFF AT SOME POINT DURING THE CASE. THE SURGEON WAS NOTIFIED BUT DID NOT TAKE FURTHER ACTION. IN REVIEWING THE CASE X-RAYS, WE COULD NOT IDENTIFY WHERE THE BROKEN PIECE WAS OR EVEN IF IT WAS IN THE PATIENT/SCREW STILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS REDUCTION BLADES SIZE 2 INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 121880

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK