BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO LOCK SCRW,SS 3.5X 18MM

    MDR report key: 24506269 · Received March 4, 2026

    Report

    Report Number
    1220246-2026-01210
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    October 16, 2025
    Report Date
    March 4, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047563
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ONE AR-8835L-18 LOW PROFILE LOCKING SCREW¿ WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT MULTIPLE SCREWS EXHIBITED SURFACE WEAR AND DAMAGED INTERNAL DRIVE FEATURES, CONSISTENT WITH IMPLANTATION AND SUBSEQUENT EXPLANTATION. FUNCTIONAL TESTING NOTED SOME RESISTANCE DURING ENGAGEMENT, WHICH IS CONSISTENT WITH THE POST-EXPLANT CONDITION. NO PROBLEM FOUND. THE COMPLAINT ALLEGATION IS NOT CONFIRMED, AS THERE IS NO ALLEGATION AGAINST THE SCREWS.

    Description of Event or Problem · 0

    ON 21-OCT-2025, A HEALTH CARE PROFESSIONAL REPORTED VIA EMAIL THAT A CLAVICLE PLATE IMPLANTED IN A PATIENT EXPERIENCED A FAILURE. ACCORDING TO THE REPORT, THE FAILURE OCCURRED APPROXIMATELY SIX MONTHS POST IMPLANTATION, AND NO TRAUMA WAS NOTED DURING THAT PERIOD. RADIOGRAPHIC IMAGES OF THE PLATE FAILURE WERE PROVIDED FOR REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2025: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2025, INVOLVING AN ORIF OF THE RIGHT CLAVICLE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, INCLUDING NO CASE DELAYS, ADDED ANESTHESIA TIME, OR ADVERSE EVENTS. THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE PROCEDURE WERE NOT PROVIDED. THE IMPLANT FAILURE WAS IDENTIFIED SIX MONTHS POSTOPERATIVELY, OCCURRING AT THE JUNCTION BETWEEN THE SCREW HOLES. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2025: THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE INITIAL PROCEDURE HAVE NOT BEEN PROVIDED AT THIS TIME. A REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN TWO WEEKS. THE PATIENT DID NOT REPORT ANY PRIOR SYMPTOMS OR EXPERIENCE A POPPING SENSATION AT THE SITE. HOWEVER, THE PATIENT BEGAN TO NOTICE PAIN, SWELLING, AND DEFORMITY AFTER ENGAGING IN ROUTINE ACTIVITIES. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/2025 BY THE SALES REPRESENTATIVE: THE REVISION IS SCHEDULED FOR 11/13/2025, AND BOTH SURGERIES WILL BE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY AS THE INITIAL SURGERY ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS THAT WERE IMPLANTED IN THE INITIAL SURGERY INCLUDE AR-2657DR DISTAL CLAVICLE PLATE, LONG, RIGHT, SS, TWO AR-2665-14H FRAGMENT SCREW, 2.4MMX1411, HEXALOBE, AR-8827-20 LOW PROFILE SCREW, 2.7 X 20 MM, CORTEX, AR-8827-24 LOW PROFILE SCREW, 2.7 X 24 MM, CORTEX, TWO AR-8827L-14 LOW PROFILE LOCKING SCREW, SS, 2.7 X 14 MM, AR-8827L-16 LOW PROFILE LOCKING SCREW, SS, 2.7 X 16 MM, TWO AR-8827L-18 LOW PROFILE LOCKING SCREW, SS, 2.7 X 18 MM, AR-8827L-20 LOW PROFILE LOCKING SCREW, SS, 2.7 X 20 MM, AR-8835-14 LOW PROFILE SCREW, SS, 3.5 X 14 MM, CORTICAL, AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AR-8835L-14 LOW PROFILE LOCKING SCREW, SS, 3.5 X 14 MM, AR-8835L-18 LOW PROFILE LOCKING SCREW, SS, 3.5 X 18 MM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2026: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. THE REVISION WAS COMPLETED SUCCESSFULLY WITHOUT ANY CASE DELAYS OR ADDITIONAL ANESTHESIA. THE PATIENT¿S CURRENT HEALTH STATUS FOLLOWING THE REVISION WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2026: THE FOLLOWING ARTHREX PRODUCTS THAT WERE EXPLANTED IN THE REVISION SURGERY INCLUDE AR-8835L-18 LOW PROFILE LOCKING SCREW, SS, 3.5 X 18 MM, AR-8835L-14 LOW PROFILE LOCKING SCREW, SS, 3.5 X 14 MM, AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AR-8835-14 LOW PROFILE SCREW, SS, 3.5 X 14 MM, CORTICAL, AR-8827L-18 LOW PROFILE LOCKING SCREW, SS, 2.7 X 18 MM, AR-8827L-16 LOW PROFILE LOCKING SCREW, SS, 2.7 X 16 MM, AR-8827L-14 LOW PROFILE LOCKING SCREW, SS, 2.7 X 14 MM, AR-8827-20 LOW PROFILE SCREW, 2.7 X 20 MM, CORTEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186766 LO-PRO LOCK SCRW,SS 3.5X 18MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 18MM UNK 00888867047563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other