BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPHAEL PEDICLE SCREW 6.5X35

    MDR report key: 7987311 · Received October 19, 2018

    Report

    Report Number
    3009051471-2018-00008
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 19, 2018
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MNI
    UDI-DI
    00841732119772
    PMA / PMN Number
    K132365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP MRI INDICATES THAT TULIP HAS SEPARATED FROM ROD. IN REVIEWING THE IMAGES, IT APPEARS THAT TULIP MAY HAVE SEPARATE FROM SCREW BODY. NO REVISION SURGERY WAS PERFORMED. THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    FOLLOW-UP MRI INDICATES THAT TULIP HAS SEPARATED FROM ROD. IN REVIEWING THE IMAGES, IT APPEARS THAT TULIP MAY HAVE SEPARATE FROM SCREW BODY. THE IMPLANTED DEVICE WAS NOT REMOVED, REVISION SURGERY DID NOT OCCUR. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828045 RAPHAEL PEDICLE SCREW 6.5X35 RAPHAEL PEDICLE SCREW 6.5X35 MNI CTL MEDICAL CORPORATION 015.3237 7KNBB 00841732119772

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR