BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB POSTERIOR SPINE TRUSS SYSTEM

    MDR report key: 19129300 · Received April 17, 2024

    Report

    Report Number
    3009189869-2024-00005
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 17, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION NOR RADIOGRAPHS PROVIDED. NO INVESTIGATION COULD BE PERFORMED WITH THE INFORMATION REPORTED. THE CAUSE OF THE EVENT COULD NOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB MEDICAL THAT TWO POSTERIOR SPINE TRUSS IMPLANTS NEEDED REVISON SURGERY. THE INTERBODIES HAD TO BE REMOVED AS PATIENT DEVELOPED INFECTION. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE COMPLAINANT BELIEVES THE INFECTION IS UNRELATED TO THE HARDWARE. (DEVICE 1 OF 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456231 4WEB POSTERIOR SPINE TRUSS SYSTEM INTERBODY FUSION DEVICE MAX 4WEB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention