BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

    MDR report key: 24701504 · Received March 26, 2026

    Report

    Report Number
    3009189869-2026-00006
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    September 5, 2025
    Report Date
    March 26, 2026
    Manufacturer
    4WEB, INC.
    Product Code
    PLF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB MEDICAL THAT A REVISION SURGERY WAS PERFORMED AS THE PATIENT'S SKIN SPLIT OPEN WHILE WALKING. THE PATIENT WAS NOTED TO HAVE NEUROPATHY WITH ASSOCIATED FOOT NUMBNESS. THE CUSTOM 4WEB DEVICE WAS EXPLANTED APPROXIMATELY 10 MONTHS FOLLOWING THE INITIAL IMPLANTATION PROCEDURE. A SUBSEQUENT PROCEDURE IS PLANNED TO IMPLANT A NEW CUSTOM 4WEB DEVICE AT THE SAME ANATOMICAL LOCATION; HOWEVER, THE REVISION SURGERY HAS NOT YET BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767362 PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT PLF 4WEB, INC. 080124.01A 104723

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention