BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7094728 · Received December 7, 2017

    Report

    Report Number
    1030489-2017-02461
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 6, 2017
    Report Date
    February 23, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 9393609,510K # K172199 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: ONLY A ~9 MM PORTION FROM THE BACK OF THE IMPLANT RETURNED FOR ANALYSIS. MICROSCOPIC FRACTURE SURFACE EXAMINATION IDENTIFIED RAYS EMANATING FROM THE ONE CORNER OF THE IMPLANT SURFACE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BRITTLE OVERLOAD. 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 BROKE. THE DEVICE CAME IN CONTACT WITH THE PATIENT. CAGE WAS PARTIALLY EXPLANTED. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877498 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 69DU

    Patients

    Seq Age Sex Outcome Treatment
    1