BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5761017 · Received June 30, 2016

    Report

    Report Number
    1030489-2016-01929
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Report Date
    June 2, 2016
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 9393008INT IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE, 9393008, 510K# K094025, IS APPROVED FOR USE. 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CAGE BROKE. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. IT COULD NOT BE REMOVED COMPLETELY OUT OF THE PATIENT AFTER IT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417656 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1