BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2239891 · Received September 8, 2011

    Report

    Report Number
    1030489-2011-01139
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE, (B)(4), 510K# K094025, IS APPROVED FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L3-L5 TLIF WITH POSTERIOR FIXATION AND PEEK INTERBODY DEVICE. WHEN PLACING THE SECOND INTERBODY DEVICE AT L3-4 THE CAGE WAS PLACED TOO FAR ANTERIOR. WHILE TRYING TO ADJUST THE CAGE, IT FELL TO THE RIGHT SIDE OF THE VERTEBRAL BODY. THE CAGE WAS UNABLE TO BE RETRIEVED AND ANOTHER DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT MAY UNDERGO A REVISION TO RETRIEVE THE CAGE AFTER RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Other