BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 14070748 · Received April 11, 2022

    Report

    Report Number
    1030489-2022-00338
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393007, 510K # K172199, UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF SPINAL THE RAPY FOR STENOSIS LUMBAR AT L5-S1. IT WAS REPORTED THAT CAGE BROKEN WHEN INSERTING IT. THE FRAGMENT OF CAGE REMAINING IN THE PATIENT. THERE WAS 60 MINUTES DELAY IN OVERALL SURGERY TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444927 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 9393007INT 72LF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown