BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMPLICITY ANTERIOR CERVICAL PLATE

    MDR report key: 2798957 · Received October 16, 2012

    Report

    Report Number
    3005739886-2012-00011
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    FMI MEDICAL INSTRUMENTS
    Product Code
    HRS
    PMA / PMN Number
    K060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS. UPON COMPLETION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6), 2012, ONE OF THE LOCKING TABS ON THE ANTERIOR CERVICAL PLATE CAME OFF WHILE THE DOCTOR WAS INSERTING THE SCREW IN THE PLATE. ANOTHER PLATE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY OR SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMPLICITY ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE 2-LEVEL HRS FMI MEDICAL INSTRUMENTS 1068FM

    Patients

    Seq Age Sex Outcome Treatment
    1