BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 23622212 · Received November 21, 2025

    Report

    Report Number
    3025141-2025-00626
    Event Type
    Injury
    Date Received
    November 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (10 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00622, 3025141-2025-00623, 3025141-2025-00624, 3025141-2025-00625, . 3025141-2025-00627 3025141-2025-00628, 3025141-2025-00629, 3025141-2025-00724, 3025141-2025-00725.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, AHRENS PM, GARLICK NI, BARBER J, TIMS EM, CLAVICLE TRIAL COLLABORATIVE GROUP. THE CLAVICLE TRIAL: A MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING OPERATIVE WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICLE FRACTURES. THE JOURNAL OF BONE AND JOINT SURGERY. AMERICAN VOLUME. 2017 AUG;99(16):1345-1354. DOI: 10.2106/JBJS.16.01112. PMID: 28816894. THIS MULTI-CENTER RANDOMIZED CONTROLLED TRIAL FOCUSED ON COMPARING PATIENTS WITH MIDSHAFT CLAVICLE FRACTURES TREATED EITHER OPERATIVELY OR NONOPERATIVELY. PATIENTS WERE TREATED BETWEEN 2008 TO 2014 AND HAD A FOLLOW-UP OF NINE MONTHS. OF THE 302 RANDOMIZED PATIENTS, 154 PATIENTS UNDERWENT SURGERY AND 147 HAD NO SURGERY. FOR THE 154 PATIENTS TREATED SURGICALLY, THEY HAD THEIR CLAVICLE FRACTURES FIXED WITH THE ACUMED PRECONTOURED CLAVICLE PLATING SYSTEM. AFTER NINE MONTHS, THERE WERE 131 PATIENTS THAT HAD SURGERY TO COMPLETE FINAL PATIENT REPORTED OUTCOME MEASUREMENTS AND 123 PATIENTS THAT DID NOT HAVE SURGERY AVAILABLE FOR ASSESSMENT. ALL PATIENTS WERE ASSESSED USING THE DISABILITIES OF THE ARM, SHOULDER, AND HAND (DASH) SCORE AND THE CONSTANT-MURLEY SCORE. IN THE OPERATIVE GROUP, COMPLICATIONS WERE REPORTED RELATED TO THE PROCEDURE IN ONE (1) PATIENT WHO NEEDED A REVISION FOR LOSS OF FIXATION, IN ONE (1) PATIENT WHO DID NOT ACHIEVE UNION, AND ONE (1) PATIENT WHO HAD THEIR PLATE REMOVED. NON-SERIOUS COMPLICATIONS INCLUDED: FOUR (4) PATIENTS WHO UNDERWENT A PLANNED REMOVAL OF THE PLATE, MINOR SCAR (3 PATIENTS), PROMINENT PLATE (2 PATIENTS), FROZEN SHOULDER (2 PATIENTS), AND AN UNRELATED ARRHYTHMIA (1 PATIENT). UNRELATED COMPLICATIONS INCLUDED THE NEED FOR ADDITIONAL SURGERY (2 PATIENTS), MALLORY-WEISS TEAR, COSTOCHONDRITIS (1 PATIENT), AND A LEFT SCAPHOID FRACTURE (1 PATIENT). FOR THE NONOPERATIVE GROUP, COMPLICATIONS WERE REPORTED FOR 19 PATIENTS THAT REQUIRED SURGERY, 13 PATIENTS HAD A NONUNION, AND 1 PATIENT THAT EXPERIENCED FROZEN SHOULDER. UNRELATED COMPLICATIONS INCLUDED AN INFECTED KNEE (1 PATIENT), AN OVERDOSE (1 PATIENT), A PULMONARY EMBOLISM (1 PATIENT), AND A RESPIRATORY TRACT INFECTION (1 PATIENT). THE DASH AND CONSTANT-MURLEY SCORES WERE ALL SIGNIFICANTLY BETTER IN THE OPERATIVE GROUP THAN THE NONOPERATIVE GROUP AT 6 WEEKS AND 3 MONTHS. BASED ON THE RESULTS OF THIS STUDY, THE AUTHORS CONCLUDED THAT TREATMENT OF MIDSHAFT CLAVICLE FRACTURES WITH PLATE FIXATION IS SAFE AND RELIABLE WITH SUPERIOR EARLY FUNCTIONAL OUTCOMES COMPARED TO NO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560700 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other