BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFT

    MDR report key: 20844680 · Received December 3, 2024

    Report

    Report Number
    MW5163127
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    March 22, 2023
    Report Date
    November 26, 2024
    Manufacturer
    CORELINK, LLC
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 I HAD AN ANTERIOR LUMBAR INTERBODY FUSION. AFTER A FEW MONTHS I WAS SUFFERING FROM SEVERE PAIN IN MY LOWER BACK AND WAS HAVING COMPLICATIONS WALKING, SITTING, STANDING ETC. AFTER BRINGING THIS TO THE ATTENTION OF MY ORTHOPEDIC SURGEON, I HAD A COMPUTED TOMOGRAPHY SCAN DONE AND UPON HIS REVIEW, IT WAS DETERMINED THAT THE HARDWARE WAS DEFECTIVE AND "BROKEN". AS A RESULT, I HAVE HAD TO HAVE A REVISION/REMOVAL/REINSERTION DONE ON (B)(6) 2024. THE MANUFACTURER IS (B)(6), AND HAVE NO INFORMATION REGARDING THE HARDWARE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850515 GRAFT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX CORELINK, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H| S| O