BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMBER SPINE ENZA A INSERTER

    MDR report key: 10734275 · Received October 26, 2020

    Report

    Report Number
    10734275
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 15, 2020
    Manufacturer
    CAMBER SPINE TECHNOLOGIES, LLC
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR FUSION LUMBAR SPINE ANTERIOR APPROACH L5-S1. DUE TO DEGENERATIVE DISC DISEASE AND LUMBAR FORAMINAL STENOSIS. SPINE CAGE INSERTER BROKE INTO TWO PIECES DURING IMPLANTATION. PIECES RETRIEVED AND GIVEN TO REPRESENTATIVE ON SITE. NO HARM TO PATIENT. PROCEDURE WAS ABLE TO BE COMPLETED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202744 CAMBER SPINE ENZA A INSERTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP CAMBER SPINE TECHNOLOGIES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA