BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2399580 · Received January 5, 2012

    Report

    Report Number
    1030489-2012-00010
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    November 30, 2011
    Report Date
    December 6, 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 PRODUCT IS NOT AVAILABLE FOR SALE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE, PART NUMBER 9392508, 510K NUMBER K094025 IS APPROVED FOR SALE IN THE UNITED STATES. 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 THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK INTERBODY CAGE CRACKED DURING INSERTION. THE SURGEON OPTED TO PLACE THE CAGE IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM MAX MSD DEGGENDORF MFG TY99

    Patients

    Seq Age Sex Outcome Treatment
    1