BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 22501331 · Received July 14, 2025

    Report

    Report Number
    3025141-2025-00263
    Event Type
    Injury
    Date Received
    July 14, 2025
    Report Date
    July 14, 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 OF THE REPORTED EVENT IS UNKNOWN. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (2 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00264.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARTICLE CITED, "WELBECK AN, NAVARRO BJ, GUISSÉ NF, ET AL. FPL RECONSTRUCTION AFTER RUPTURE FOLLOWING VOLAR PLATE FIXATION OF DISTAL RADIUS FRACTURES: A CASE SERIES. JOURNAL OF HAND SURGERY GLOBAL ONLINE. 2025 MAY;7(3):100693. DOI: 10.1016/J.JHSG.2025.01.002. PMID: 40496413; PMCID: PMC12147572." THIS RETROSPECTIVE CASE SERIES REPORTS THE EXPERIENCE AT ONE TERTIARY CENTER WITH FLEXOR POLLICIS LONGUS (FPL) RECONSTRUCTION AFTER FIXATION OF A DISTAL RADIUS FRACTURE (DRF) USING ORIF. PATIENTS TREATED BETWEEN JANUARY 1, 2013, AND JUNE 12, 2023, WERE ELIGIBLE FOR INCLUSION. AFTER REVIEWING MEDICAL RECORDS, PATIENTS WERE SELECTED FOR STUDY INCLUSION IF THE FPL RECONSTRUCTION FOLLOWED VOLAR LOCKING PLATE (VLP) FIXATION. PATIENTS WHO HAD SPONTANEOUS FPL RUPTURES IN THE SETTING OF CLOSED REDUCTIONS, DIAGNOSES OF FPL TENOSYNOVITIS WITHOUT RUPTURE, RUPTURE OF OTHER FLEXOR OR EXTENSOR TENDONS, OR FPL RUPTURE OF A DIFFERENT ETIOLOGY WERE EXCLUDED FROM THE STUDY. PREOPERATIVE RADIOGRAPHS WERE ANALYZED FOR SOONG GRADING AND FRACTURE REDUCTION PARAMETERS. THE DATA WERE COMMINGLED FOR DISTAL RADIUS PLATES FROM ACUMED (2), SYNTHES (3), SMITH & NEPHEW (1), AND MEDARTIS (1). THE VOLAR LOCKING PLATES WERE NOT SPECIFIED. RECORD REVIEW IDENTIFIED 15 PATIENTS WHO HAD UNDERGONE FPL RECONSTRUCTION FOR RUPTURE AFTER VLP FIXATION. FIFTEEN PATIENTS (AVERAGE AGE: 63 YEARS) UNDERWENT VLP REMOVAL AND RECONSTRUCTION TO RESTORE FPL FUNCTION. RUPTURE OCCURRED AT A MEDIAN OF 6 YEARS 3 MONTHS AFTER DRF REPAIR. ALL PATIENTS WERE TREATED WITH VLP REMOVAL. EIGHT PATIENTS WERE TREATED WITH CONCOMITANT FLEXOR DIGITORUM SUPERFICIALIS (FDS-4) TO FPL TRANSFER; FIVE UNDERWENT AN INTERPOSED PL AUTOGRAFT, WHEREAS THE REMAINING TWO UNDERWENT AN INTERPOSED FCR AUTOGRAFT, WITH ONE BEING A PARTIAL HARVEST AND THE OTHER A COMPLETE HARVEST. THREE HAD AN EXTENDED CARPAL TUNNEL RELEASE FOR EXPOSURE, AND ONE HAD MEDIAN NERVE NEUROLYSIS AFTER IT WAS FOUND TO BE SCARRED TO THE RESIDUAL FPL TENDON. THERE WERE NO ADDITIONAL SURGERIES ON ANY PATIENT. THE AUTHORS CONCLUDED THAT FLEXOR POLLICIS LONGUS RUPTURE IS A KNOWN COMPLICATION OF VLP FIXATION OF DRF, OCCURRING OVER A WIDE RANGE OF TIME AFTER INITIAL FRACTURE FIXATION. IN CASES OF RUPTURE, SURGEONS CAN SUCCESSFULLY RECONSTRUCT THE FPL USING TENDON TRANSFERS OR INTERPOSITION AUTOGRAFTS, WITH IMPROVEMENT SEEN AFTER BOTH TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426548 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other