BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE

    MDR report key: 17445947 · Received August 2, 2023

    Report

    Report Number
    3009189869-2023-00008
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 5, 2023
    Report Date
    December 5, 2023
    Manufacturer
    4WEB, INC.
    Product Code
    OVD
    UDI-DI
    00812998045075
    PMA / PMN Number
    K200002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED TO THE MANUFACTURER. INVESTIGATION IS NOT YET COMPLETE. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE INNNER BLISTER SEAL WAS FOUND TO BE INTACT. THIS IS AN ISOLATED INCIDENT FOR BROKEN BLISTER SEAL. AS PART OF INVESTIGATION, A SEAL-STRENGTH TEST WAS PERFORMED ON THE RETURNED PRODUCT AND THE RESULT WAS FOUND TO BE ACCEPTABLE. THE EXACT CAUSE OF DEVICE PROBLEM COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT UPON OPENING THE FIRST OUTER BLISTER SEAL AND PROCEEDING TO OPEN THE INNER BLISTER OF A STERILE PACKAGED IMPLANT, IT WAS NOTICED THAT A PART OF THE EXTERNAL PULL TAB WAS LOOSE FROM THE SEAL. ANOTHER STERILE IMPLANT WAS OPENED TO CONTINUE WITH THE SURGERY. THERE WAS NO IMPACT TO THE SURGERY AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740997 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD 4WEB, INC. ASTS-SA-LG1612-SP D004 00812998045075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other