BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2356059 · Received December 2, 2011

    Report

    Report Number
    1030489-2011-01550
    Event Type
    Injury
    Date Received
    December 2, 2011
    Report Date
    November 7, 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 DEVICE IS NOT APPROVED FOR SALE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE, PART NUMBER 9393010, 510K NUMBER K094025, IS APPROVED FOR SALE IN THE UNITED STATES. THE DEVICE OR APPLICABLE IMAGING STUDIES HAS NOT BEEN 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 SPONDYLOLISTHESIS UNDERWENT SURGERY FOR TLIF AT L4-5 WITH PEEK INTERBODY DEVICE AND COMPETITOR'S POSTERIOR ROD/PEDICLE SCREW FIXATION. POST-OP THE INTERBODY DEVICE BACKED OUT AND THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE DEVICE. DURING THE REVISION, LOOSENED PEDICLE SCREWS WERE REPLACED. REPORTEDLY THE LOOSENED FIXATION CONTRIBUTED TO THE INTERBODY DEVICE MIGRATION.

    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 UE09

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention POSTERIOR RODS, PEDICLE SCREWS