BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 14MMCORT

    MDR report key: 21322643 · Received February 6, 2025

    Report

    Report Number
    1220246-2025-00253
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    May 9, 2022
    Report Date
    September 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047280
    PMA / PMN Number
    K203239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT, SUCH AS FOREIGN BODY SENSITIVITY. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THE FAILURE WAS RECEIVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6) 2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBILITY AND NEEDED PHYSICAL THERAPY. A YEAR OR SO LATER, THE PATIENT CONSULTED A DIFFERENT SURGEON WHO SUGGESTED A THIRD SURGERY TO CLEAN UP SCAR TISSUE. BEFORE SURGERY ON (B)(6) 2024, THE PATIENT RECEIVED KETAMINE INFUSIONS TO GET COMPLEX REGIONAL PAIN SYNDROME UNDER CONTROL. AFTER THE SURGERY, THE PATIENT WAS INFORMED THAT A FOURTH CARTILAGE BREAK WAS MISSED IN THE INITIAL SURGERY. THE THIRD SURGERY CLEARED UP THE SCARS AND LESIONS, IMPROVED THE PATIENT'S MOBILITY, AND RETURNED NORMAL LEG COLOR. THE PATIENT IS WORKING ON THE REMISSION OF COMPLEX REGIONAL PAIN SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919950 LO-PRO SCRW TM,SS 3.5X 14MMCORT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 14MMCORT 12438237 00888867047280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other