BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7653985 · Received July 1, 2018

    Report

    Report Number
    1030489-2018-00938
    Event Type
    Malfunction
    Date Received
    July 1, 2018
    Date of Event
    June 1, 2018
    Report Date
    July 1, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393007, 510K #K094025 AND UPN #(B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OPERATIVELY THE CAGE WHICH WAS DISLOCATED FROM SITE WHILE IMPLANTATION. THE CAGE WAS BROKEN. FRAGMENTS WERE REMAINED IN PATIENT. NO PATIENT COMPLICATIONS WERE OCCURRED DUE TO THIS REPORTED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496079 CRESCENT SPINAL SYSTEM MAX MSD DEGGENDORF MFG NA 27EY

    Patients

    Seq Age Sex Outcome Treatment
    1