BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 22844050 · Received August 19, 2025

    Report

    Report Number
    3025141-2025-00340
    Event Type
    Injury
    Date Received
    August 19, 2025
    Report Date
    August 19, 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 (2 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00341.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, FISHLEY WG, BALDOCK T, HILLEY AJ, ET AL. THE FRACTURE ANKLE IMPLANT REVIEW (FAIR) STUDY : A NATIONAL MULTICENTRE RETROSPECTIVE REVIEW OF PRACTICE IN IMPLANT CHOICE, FIXATION METHODS, AND OUTCOMES IN FIXATION OF THE FIBULA IN ANKLE FRACTURES. BONE & JOINT OPEN. 2025 JUL;6(7):841-849. DOI: 10.1302/2633-1462.67.BJO-2025-0009.R1. PMID: 40675589; PMCID: PMC12270632. THIS STUDY PRESENTED RETROSPECTIVE DATA FROM 22 PARTICIPATING CENTERS IN THE UK IN 2019. THE STUDY PROVIDED A DESCRIPTIVE ANALYSIS OF PATIENT OUTCOMES USING DIFFERENT FIXATION METHODS FOR ANKLE FRACTURES. A TOTAL OF 1,471 ANKLE FRACTURES UNDERWENT FIXATION WITH ONE-THIRD TUBULAR PLATES (N=883), A LOCKING PLATE (N=470), OR OTHER, UNSPECIFIED METHODS (N=118). THE IMPLANTS USED INCLUDED THE FOLLOWING MANUFACTURERS: STRYKER (N=592), DEPUY SYNTHES (N=481), SMITH & NEPHEW (N=74), ACUMED (N=23), PARAGON (N=4), AND UNDOCUMENTED (N= N/A). IT WAS NOTED THAT PATIENTS THAT USED LOCKING PLATES OR OTHER METHODS WERE MORE COMMONLY USED TO TREAT PATIENTS WITH DIABETES, OSTEOPOROSIS, OR WERE IMMUNOCOMPROMISED. THE COMPLICATIONS REPORTED INCLUDED LATERAL WOUND BREAKDOWN IN 56 PATIENTS (3.8%) AND INFECTION IN 89 PATIENTS (5.9%). IN GENERAL, USE OF LOCKING PLATES WERE ASSOCIATED WITH MORE COMPLICATIONS COMPARED TO USE OF ONE-THIRD TUBULAR PLATES. ANALYSIS BY BRAND OF IMPLANTS OF LOCKING PLATES DID NOT SHOW ANY SIGNIFICANT DIFFERENCES BETWEEN THE DIFFERENT MANUFACTURERS. THE AUTHORS CONCLUDED THAT SURGEONS REVIEW THE USE OF LOCKING PLATES, AS THEY HAVE AN INCREASED COST AND CHANCE OF LATERAL WOUND COMPLICATIONS COMPARED TO THE USE OF ONE-THIRD TUBULAR PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253673 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other