BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2414842 · Received January 13, 2012

    Report

    Report Number
    1030489-2012-00048
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 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 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 CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PIECE OF THE PEEK CAGE WAS BROKEN OFF DURING INSERTION AT L5-S1. THE FRAGMENT WAS RECEIVED AND THE CAGE WAS LEFT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM MAX MSD DEGGENDORF MFG UK42

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR