BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

    MDR report key: 24492416 · Received March 2, 2026

    Report

    Report Number
    3009189869-2026-00005
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 2, 2026
    Manufacturer
    4WEB, INC.
    Product Code
    QNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE PRODUCTION RECORDS WERE REVIEWED FOR THE PRODUCT INVOLVED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT A 4WEB CUSTOM-MADE DEVICE WAS EXPLANTED APPROXIMATELY THREE MONTHS FOLLOWING THE INITIAL SURGERY. THE PATIENT REPORTEDLY UNDERWENT MULTIPLE SURGICAL PROCEDURES (PRIOR TO THE INITIAL SURGERY WITH 4WEB DEVICE), WHICH RESULTED IN TISSUE CLOSURE COMPLICATIONS AND A DELAYED WOUND. THE 4WEB DEVICE WAS EXPLANTED ON (B)(6) 2025 AND REPLACED WITH AN ANTIBIOTIC SPACER. THE PATIENT WILL UNDERGO AN ADDITIONAL PROCEDURE TO REPLACE THE SPACER WITH A 4WEB CUSTOM-MADE DEVICE; HOWEVER, THE DATE OF THE PLANNED SURGERY HAS NOT YET BEEN FINALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298838 PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN 4WEB, INC. 061625.08B JI55336

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other