BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELBOW PLATING SYSTEM

    MDR report key: 21981334 · Received May 7, 2025

    Report

    Report Number
    3025141-2025-00143
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    May 31, 2025
    Report Date
    May 7, 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.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARITCLE CITED, "OGASAWARA M, TANAKA H, TSUKANO H, TASHIMA H, YAMAMOTO T. INCIDENCE AND RISK FACTORS OF ULNAR NEUROPATHY AFTER THE SURGICAL TREATMENT OF DISTAL HUMERAL FRACTURES. CUREUS. 2025 MAR;17(3):E81506. DOI: 10.7759/CUREUS.81506. PMID: 40308408; PMCID: PMC12042785", THE AUTHORS INVESTIGATED COMPLICATIONS FOR NEUROPATHY ASSOCIATED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR DISTAL HUMERAL FRACTURES. THIS STUDY USING TWO PRECONTOURED ANATOMICAL LOCKING PLATES FOR DISTAL HUMERAL FRACTURES. ORTHOGONAL PLATING WAS USED IN 15 CASES, AND PARALLEL PLATING WAS USED IN 25 CASES. THE FIXATION IMPLANT MANUFACTURER WAS DEPUY SYNTHES (RAYNHAM, MA) IN 13 CASES, STRYKER (KALAMAZOO, MI) IN 12 CASES, MEIRA CORPORATION (NAGOYA, JAPAN) IN 12 CASES, ACUMED (PORTLAND, OR) IN TWO CASES, AND ZIMMER BIOMET (WARSAW, IN) IN ONE CASE. IN ALL CASES, BONE HEALING WAS OBSERVED, AND NO IMPLANT FAILURES WERE NOTED DURING THE HEALING PROCESS. THE INCIDENCE OF ULNAR NEUROPATHY WAS 35% (14/40 PATIENTS), INCLUDING ONE PATIENT WITH CONCURRENT RADIAL NEUROPATHY. AMONG PATIENTS WHO DEVELOPED NEUROPATHY, THE CONDITION RESOLVED IN SEVEN DURING THE STUDY PERIOD, WHILE SEVEN REMAINED SYMPTOMATIC. ALL PATIENTS WITH PERSISTENT SYMPTOMS HAD TYPE C1 FRACTURES. THEIR CONCLUSION WAS "POSTOPERATIVE ULNAR NERVE NEUROPATHY WAS OBSERVED IN 14/40 CASES (35%) IN OUR STUDY. THE RISK FACTORS FOR ITS OCCURRENCE WERE INTRA-ARTICULAR FRACTURES AND AGE OF <65 YEARS, WHICH IS A RELATIVELY YOUNG AGE. OUR RESULTS SUGGEST THAT THE COMBINATION OF TRAUMA-INDUCED DAMAGE TO THE ULNAR NERVE AND SURGICAL INVASION MIGHT LEAD TO NEUROPATHY. THEREFORE, THOROUGH PREOPERATIVE EXPLANATIONS AND OBTAINING INFORMED CONSENT FROM PATIENTS REGARDING THE RISK OF NEUROPATHY ARE ESSENTIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035685 ELBOW PLATING SYSTEM PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other