BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5200003 · Received November 4, 2015

    Report

    Report Number
    1030489-2015-02905
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS DEVICE IS NOT APPROVED FOR SALE IN THE UNITED STATES, HOWEVER A LIKE DEVICE, PART NUMBER 9392508, 510K NUMBER K094025, IS APPROVED FOR SALE IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TLIF AT LEVELS L3-L5 TO TREAT SPONDYLOLISTHESIS. DURING SURGERY, THE IMPLANT MIGRATED ANTERIORLY WHEN SURGEON WAS PLACING THE CAGE INTO L3-L4. THE SURGEON REMOVED THE CAGE WITH AN ADJUSTER (CFN NOT PROVIDED), PLACED PEEK CAGE INSTEAD WITH ADJUSTING PLACING ANGLE TO MEDIAL, AND FINISHED HIS PROCEDURE. THE EVENT DELAYED SURGICAL TIME MORE THAN 60 MINUTES. THE SURGEON COMMENTED THAT HE INITIALLY THOUGHT HE MIGHT HAVE BROKE ANTERIOR LONGITUDINAL LIGAMENT BUT WAS CONSIDERING THAT THE POINT HE STARTED TO ROTATE THE CAGE MIGHT BE TOO LATERAL THAT MIGHT PUSHED THE CAGE TO ANTERIOR FROM THE RESULT OF THE EVENT WHICH INVOLVED NO VESSEL DAMAGES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE FOLLOWING DAY THE SURGEON FOUND ON X-RAY IMAGE THAT THE CAGE WAS PLACED TOO LATERAL, SO A REVISION WAS PLANNED ON (B)(6) 2015. IN THE REVISION SURGERY, THE PEEK WAS REMOVED AND PEEK WAS INSERTED AT A DIFFERENT CITE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731221 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA ZX63

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention