BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE PITUITARY RONGEUR STR 4 MM

    MDR report key: 2050010 · Received March 28, 2011

    Report

    Report Number
    9617544-2011-00112
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING PROCEDURE. THE SURGEON DIDN'T OVERPOWERED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE PITUITARY RONGEUR STR 4 MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 055092

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK