BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 3073009 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01244
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE AT UNKNOWN LEVELS VIA TLIF. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO CAGE MIGRATION ANTERIOR. THE PATIENT COMPLICATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174762 CRESCENT SPINAL SYSTEM MAX MSD DEGGENDORF MFG NA VR27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention