BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP

    MDR report key: 23221380 · Received October 6, 2025

    Report

    Report Number
    1220246-2025-04441
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    August 22, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO A PATIENT-SPECIFIC EVENT DUE TO DISCOMFORT RELATED TO A KNOWN HISTORY OF METAL HYPERSENSITIVITY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 09/26/2025, A PATIENT SUBMITTED A PHONE INQUIRY REQUESTING THE MATERIAL COMPOSITION OF AN ARTHREX IMPLANT, DESCRIBED AS A 2.4MM ARTHREX TITANIUM VOLAR DISTAL RADIUS PLATE AND SCREWS. THE PATIENT UNDERWENT A DISTAL RADIAL FRACTURE PROCEDURE ON THE RIGHT WRIST ON (B)(6) 2025, DURING WHICH THE VOLAR DISTAL RADIUS PLATE AND SCREWS WERE IMPLANTED. APPROXIMATELY TWO AND A HALF WEEKS POST-SURGERY, THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, STIFFNESS, AND HEAT LOCALIZED TO THE RIGHT WRIST AND HAND. THE SYMPTOMS DID NOT EXTEND BEYOND THE INCISION SITE, AND THE PATIENT BELIEVES THEY MAY BE EXPERIENCING AN ALLERGIC REACTION. BLOODWORK REVEALED ELEVATED PHOSPHATE AND ABSOLUTE LYMPHOCYTE COUNTS. THE PATIENT REPORTED NO SIGNS OF INFECTION AND WAS PRESCRIBED PREDNISONE AND A MEDROL DOSE PACK, WHICH DID NOT ALLEVIATE THE SYMPTOMS. THE PATIENT PREVIOUSLY UNDERWENT A LYMPHOCYTE TRANSFORMATION TEST (LTT) FIVE YEARS AGO, WHICH CONFIRMED ALLERGIES TO NICKEL, COBALT, VANADIUM, AND MOLYBDENUM. THE PATIENT IS NOW SEEKING CONFIRMATION ON WHETHER THE IMPLANTED COMPONENTS CONTAIN ANY MATERIALS OTHER THAN TITANIUM. ADDITIONAL INFORMATION WAS PROVIDED ON 09/30/2025: THE FOLLOWING ARTHREX IMPLANTS WERE USED IN THE PATIENT'S DISTAL RADIAL FRACTURE PROCEDURE ON THE RIGHT WRIST, PERFORMED ON (B)(6) 2025 INCLUDE, THREE AR-8724VCL-18 KREULOCK COMPRESSION SCREW (2.4 MM X 18 MM), AR-8724VCL-16 KREULOCK COMPRESSION SCREW (2.4 MM X 16 MM), AR-8735-16 LOW PROFILE SCREW, CORTICAL (3.5 X 16 MM), TWO AR-8735-14 LOW PROFILE SCREW, CORTICAL (3.5 X 14 MM), AR-8916VSR-03 VOLAR DISTAL RADIUS PLATE, STANDARD, RIGHT, 3 HOLE, AR-8916CX24-20 LOW PROFILE SCREW, CORTEX, TI, 2.4 MM X 20 MM. THE PATIENT HAS REQUESTED INFORMATION REGARDING THE MATERIAL COMPOSITION OF THESE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340148 LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X14MM,DRP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other