BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2332471 · Received November 10, 2011

    Report

    Report Number
    1030489-2011-01456
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE, PART NUMBER 9392509, 510K NUMBER K094025, IS APPROVED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH KYPHOSIS UNDERWENT A SPINAL PROCEDURE FOR IMPLANT OF PEEK DEVICE VIA TLIF AT L3-4 AND L5-S1 AND FOR POSTERIOR FIXATION T11-L5. WHILE ROTATING THE PEEK CAGE IN THE L5-S1 DISC SPACE, THE CAGE WAS BROKEN. THE SURGEON REMOVED MOST OF THE FRAGMENTS AND IMPLANTED ANOTHER DEVICE WITH NO FURTHER COMPLICATIONS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG UL36

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention