BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2364585 · Received December 9, 2011

    Report

    Report Number
    1030489-2011-01579
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 14, 2011
    Report Date
    November 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 SALE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE, PART NUMBER 9392507, 510K NUMBER K094025, IS APPROVED FOR SALE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH STENOSIS UNDERWENT A PROCEDURE FOR TLIF AT L3-4 AND L4-5. THE FIRST CAGE AT L3-4 WAS BROKEN APPROXIMATELY 6MM FROM THE INSERTER CONNECTION DURING INSERTION. ALL BROKEN PIECES WERE REMOVED. PER THE SURGEON, THE DISC SPACE WAS VERY NARROW. 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 TY98

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR