BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2311664 · Received October 27, 2011

    Report

    Report Number
    1030489-2011-01374
    Event Type
    Injury
    Date Received
    October 27, 2011
    Report Date
    September 29, 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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE, PART NUMBER 9393008, 510K # K094025, IS APPROVED FOR USE. THE DEVICE OR APPLICABLE IMAGING STUDIES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH SPINAL STENOSIS UNDERWENT A PROCEDURE FOR TLIF AT L5-S1 WITH PEEK DEVICE AND POSTERIOR FIXATION. PATIENT COMPLAINED OF NEUROLOGIC MANIFESTATION DUE TO CAGE BACK APPROXIMATELY 3 WEEKS POST-OP. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE INTERBODY DEVICE.

    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 TV41

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention