BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 2914257 · Received December 6, 2012

    Report

    Report Number
    1831750-2012-12472
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAKE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISTOOL SURGERY STOOL FZM STRYKER MEDICAL 0830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1