BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SYSTEM

    MDR report key: 12603530 · Received October 11, 2021

    Report

    Report Number
    1030489-2021-01251
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 11, 2021
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG # 9392512, 510K # K172199, UDI# (B)(4) IS APPROVED FOR SALE IN THE US. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISC DISEASE FOR TLIF SPINAL THERAPY AT LEVEL 1. IT WAS REPORTED THAT THE CAGE BROKE EASILY DURING THE INTRODUCTION. THE FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. THERE WAS DELAY OF 10 MINUTES IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506426 CRESCENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 9392512INT 05LC

    Patients

    Seq Age Sex Outcome Treatment
    1