BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN R3CON NON-LOCKING SCREW 3.5X12MM

    MDR report key: 24856733 · Received April 13, 2026

    Report

    Report Number
    3008650117-2026-00167
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 4, 2025
    Report Date
    April 13, 2026
    Manufacturer
    PARAGON 28
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: P82-001-1237-SK, R3FLEX IMPLANT W/INSR SK, UNKNOWN LOT. UNKNOWN R3CON LOCKING 3.5X14 MM SCREW X2. UNKNOWN R3CON LOCKING 3.5X16 MM SCREW. UNKNOWN R3CON NON-LOCKING 3.5X12 MM SCREW X2. UNKNOWN R3CON NON-LOCKING 3.5X14 MM SCREW. UNKNOWN MINI MONSTER 4MM SCREW X2. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST IMPLANTATION OF A LEFT ANKLE STABILIZATION SYSTEM WITH SCREWS, THE PATIENT EXPERIENCED PAIN THAT WAS LIMITING ACTIVITY AND PARTICIPATION IN PT. PATIENT HAS BEEN REFERRED TO A PAIN SPECIALIST TO TREAT SUSPECTED LEFT SAPHENOUS NEURITIS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923104 UNKNOWN R3CON NON-LOCKING SCREW 3.5X12MM SCREW, FIXATION, BONE HWC PARAGON 28 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other SEE H11 NARRATIVE