BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4WEB MEDICAL

    MDR report key: 13471798 · Received February 7, 2022

    Report

    Report Number
    3009189869-2022-00003
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 7, 2022
    Report Date
    February 7, 2022
    Manufacturer
    4WEB, INC.
    Product Code
    PLF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON DETERMINED THAT THE IMPLANT STRUCTURE WAS INTACT AND DECIDED TO COMPLETE THE SURGERY. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING AND/OR DESIGN THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED IN THE PATIENT. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON DETERMINED THAT THE IMPLANT STRUCTURE WAS INTACT AND DECIDED TO COMPLETE THE SURGERY. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING AND/OR DESIGN THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED IN THE PATIENT. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT THE THREADED PORTION OF THE CUSTOM IMPLANT BROKE WHILE THE SURGEON ATTEMPTED TO USE THE IMPLANT INSERTER AS A LEVER ARM TO TURN THE IMPLANT IN THE DEFECT AREA. THE INSERTION FEATURE BROKE FREE OF THE IMPLANT. THE SURGEON DETERMINED THAT THE STRUCTURE OF THE IMPLANT WAS INTACT AND PROCEEDED TO COMPLETE THE SURGERY WITH THE SAME IMPLANT. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT THE THREADED PORTION OF THE CUSTOM IMPLANT BROKE WHILE THE SURGEON ATTEMPTED TO USE THE IMPLANT INSERTER AS A LEVER ARM TO TURN THE IMPLANT IN THE DEFECT AREA. THE INSERTION FEATURE BROKE FREE OF THE IMPLANT. THE SURGEON DETERMINED THAT THE STRUCTURE OF THE IMPLANT WAS INTACT AND PROCEEDED TO COMPLETE THE SURGERY WITH THE SAME IMPLANT. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594991 4WEB MEDICAL PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT PLF 4WEB, INC. 110521.03A JI23130

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other