BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE

    MDR report key: 5050584 · Received September 2, 2015

    Report

    Report Number
    3004893332-2015-00009
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    April 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K101848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EXPLANTED.

    Description of Event or Problem · 1

    SCREW BACKOUT WAS OBSERVED AT 14 WEEKS POST-OPERATIVE X-RAY FROM THE TIME OF SURGERY. INTERBODIES WERE USED AT EACH LEVEL AND NO REVISION SURGERY IS SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582670 SAPPHIRE SPINAL INTERVERTEBRAL BODY FIXATION KWQ SPINAL ELEMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other