BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COALESCE THORACOLUMBAR INTERBODY FUSIO

    MDR report key: 11915362 · Received June 1, 2021

    Report

    Report Number
    2031966-2021-00075
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 1, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MAX
    PMA / PMN Number
    K203201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AS NO PRODUCT PROBLEM WAS ALLEGED. RADIOGRAPH PROVIDED. REVIEW OF THE REPORTED EVENT IDENTIFIED SURGEON NOTED AN INSUFFICIENT CONSTRUCT REQUIRING EXTENSION. NO PRODUCT MALFUNCTION SUGGESTED OR IDENTIFIED. PATIENT IS REPORTEDLY DOING WELL POST-OP. NO ADDITIONAL INVESTIGATION REQUIRED. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS POTENTIAL ADVERSE EFFECTS RESULTING FROM USE OF THE COALESCE THORACOLUMBAR INTERBODY FUSION SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: LOSS OF FIXATION IN BONE. PAIN, DISCOMFORT AND ABNORMAL SENSATIONS DUE TO PRESENCE OF THE IMPLANT. ADVERSE EFFECTS MAY NECESSITATE RE-OPERATION, REVISION OR REMOVAL SURGERY. IMPLANT REMOVAL SHOULD BE FOLLOWED BY ADEQUATE POSTOPERATIVE MANAGEMENT..." "...WARNINGS AND PRECAUTIONS: CORRECT SELECTION OF THE COALESCE THORACOLUMBAR INTERBODY FUSION SYSTEM IMPLANT COMPONENTS IS EXTREMELY IMPORTANT. CAREFULLY SELECT THE APPROPRIATE DEVICE SIZE BASED ON THE NEEDS OF EACH INDIVIDUAL PATIENT..."

    Description of Event or Problem · 1

    ON (B)(6) 2021 A SPINAL PROCEDURE WAS CONDUCTED AT T10. ON (B)(6) 2021 A FOLLOW-UP VISIT OCCURRED DUE TO REPORTED IMMEDIATE BACK/LEG PAIN. THE SURGEON NOTED HE SHOULD HAVE GONE TO PELVIS. ON (B)(6) 2021 AN ANTERIOR LUMBAR INTERBODY FUSION REVISION SURGERY WAS CONDUCTED WHERE THE CAGES WERE REMOVED AND THE CONSTRUCT WAS EXTENDED TO THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808268 NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COALESCE THORACOLUMBAR INTERBODY FUSIO INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INCORPORATED 2000-00-091108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention