BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION POCT SYSTEM

    MDR report key: 5040308 · Received August 28, 2015

    Report

    Report Number
    3008524126-2015-00024
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    July 30, 2015
    Report Date
    October 19, 2015
    Manufacturer
    ORTHOFIX INC
    Product Code
    KWP
    UDI-DI
    18257200094097
    PMA / PMN Number
    150822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING THE PROCEDURE, THE PURSUADER (ROD REDUCER) WOULD NOT SEAT ON THE CENTURION SCREWS RESULTING IN A DELAY IN THE SURGERY. NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573189 CENTURION POCT SYSTEM POSTERIOR CERVICAL SYSTEM INSTRUMENTATION KWP ORTHOFIX INC 69-1072 39772-PE03 18257200094097

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other