BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPLATE CERVICAL TI IFD

    MDR report key: 1416744 · Received July 17, 2009

    Report

    Report Number
    3003597504-2009-00002
    Event Type
    Injury
    Date Received
    July 17, 2009
    Date of Event
    June 19, 2009
    Report Date
    July 15, 2009
    Manufacturer
    RSB SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K071922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A SINGLE LEVEL ACDF WAS PERFORMED IN 2009, USING AN INTERPLATE CERVICAL TITANIUM IFD FOR FIXATION. THE PATIENT SUBSEQUENTLY REPORTED PAIN. THE INTERPLATE WAS REMOVED AT APPROX 4MONTHS LATER. AT THAT TIME, FUSION HAD OCCURRED. THE GRAFT HAD MIGRATED POSTERIORLY PRIOR TO FUSION AND WAS IMPINGING ON THE CANAL. THE GRAFT WAS REPORTED TO BE UNDERSIZED AND THEREFORE ABLE TO MOVE IN THE INTERVERTEBRAL SPACE. THERE WAS NO DEVICE MALFUNCTION BUT THE INCIDENT IS BEING REPORTED BECAUSE SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE CERVICAL TI IFD INTERVERTEBRAL FUSION DEVICE WITH BONE KWQ RSB SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R