BEUDAMED
    FDA Adverse Event Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2770498 · Received October 3, 2012

    Report

    Report Number
    1030489-2012-01792
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A PATIENT UNDERWENT A PROCEDURE AT L5-S VIA TLIF USING A CAGE WITH A COMPETITOR'S SPINAL SYSTEMS TO TREAT ISTHMIC SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE WAS FRACTURED DURING INSERTION USING AN INSERTER. A HALF OF CAGE AND OTHER SMALL FRAGMENTS WERE RETRIEVED, AND THE OTHER HALF REMAINED IN THE PATIENT. ANOTHER CAGE WAS IMPLANTED IN THE SAME LEVEL. IT WAS REPORTED THAT THE INTERVERTEBRAL SPACE WAS VERY NARROW, AND RESISTANCE WAS FELT DURING THE CAGE INSERTION. THE HOSPITAL REQUESTED TO SUBMIT A CUSTOMER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM MAX MSD DEGGENDORF MFG NA UE06

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other