BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2332484 · Received November 10, 2011

    Report

    Report Number
    1030489-2011-01455
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    NA
    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 9393007, 510K NUMBER K094025, IS APPROVED FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO INFORMATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR TLIF AT L4-5 WITH PEEK IMPLANT. AFTER INSERTION, THE SURGEON NOTICED A CRACK ON THE CAGE NEAR THE INSERTION HOLE. THE CAGE WAS IN PROPER POSITION AND THE SURGEON OPTED TO LEAVE IT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS.

    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 UE06

    Patients

    Seq Age Sex Outcome Treatment
    1