BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 22801054 · Received August 13, 2025

    Report

    Report Number
    3025141-2025-00330
    Event Type
    Injury
    Date Received
    August 13, 2025
    Report Date
    August 13, 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 (17 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00320, 3025141-2025-00321, 3025141-2025-00322, 3025141-2025-00323, 3025141-2025-00324, 3025141-2025-00325, 3025141-2025-00326, 3025141-2025-00327, 3025141-2025-00328, 3025141-2025-00329, 3025141-2025-00331, 3025141-2025-00332, 3025141-2025-00333, 3025141-2025-00334, 3025141-2025-00335, 3025141-2025-00336.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARTICLE CITED, "SHIN SJ, SOHN HS, DO NH. A CLINICAL COMPARISON OF TWO DIFFERENT DOUBLE PLATING METHODS FOR INTRAARTICULAR DISTAL HUMERUS FRACTURES. JOURNAL OF SHOULDER AND ELBOW SURGERY. 2010 JAN;19(1):2-9. DOI: 10.1016/J.JSE.2009.05.003. PMID: 19574065." THIS STUDY COMPARED CLINICAL OUTCOMES IN PATIENTS WITH INTRAARTICULAR DISTAL HUMERUS FRACTURES TREATED USING 2 DIFFERENT DOUBLE PLATING METHODS. SEVENTEEN PATIENTS WERE TREATED BY EITHER A PERPENDICULAR PLATING (GROUP I) OR 18 PATIENTS WERE TREATED BY PARALLEL PLATING (GROUP II) METHODS. A 3.5-MM RECONSTRUCTION PLATE WAS CONTOURED TO FIT ALONG THE POSTERIOR ASPECT OF THE LATERAL COLUMN. IN THE MEDIAL COLUMN, 2 DIFFERENT PLATES WERE USED. TEN OF 17 PATIENTS RECEIVED AN UNSPECIFIED 3.5-MM RECONSTRUCTION PLATE AFTER CONTOURING ALONG THE MEDIAL COLUMN AND 7 PATIENTS RECEIVED A PRE-CONTOURED ANATOMICAL PLATE (ACUMED, HILLSBORO, OR). EIGHTEEN PATIENTS RECEIVED PRE-CONTOURED ANATOMICAL PLATES ALONG EACH SUPRACONDYLAR RIDGE APPROXIMATELY PARALLEL TO EACH OTHER (GROUP II). ALL PLATES USED IN THIS STUDY WERE MADE OF TITANIUM. ALL SURGERIES WERE PERFORMED BY A SINGLE SURGEON IN ONE INSTITUTE WITHIN 5 DAYS OF INJURY, EXCEPT FOR 1 PATIENT IN GROUP II. IN THIS PATIENT, SURGERY WAS DELAYED UNTIL 2 WEEKS AFTER A FALL DUE TO INTERNAL ORGAN INJURIES. SEVEN PATIENTS HAD AN INJURY OF THE DOMINANT EXTREMITY IN GROUP I AND 11 IN GROUP II. COMPLICATIONS DEVELOPED IN 6 PATIENTS IN GROUP I AND IN 8 IN GROUP II. TWO (2) PATIENTS WHO UNDERWENT PERPENDICULAR PLATING (GROUP I) HAD NONUNION. BOTH PATIENTS HAD A REVISION SURGERY FOR NONUNION GOING FROM PERPENDICULAR PLATING TO PARALLEL PLATING AND ACHIEVED UNION. ONE NONUNION WAS DUE TO PLATE LOOSENING WITH SCREW PULLOUT. THE OTHER (1) PATIENT DEVELOPED SEVERE ARTHROFIBROSIS AND NEEDED OPEN ARTHROLYSIS. TWO (2) PATIENTS HAD TRANSIENT ULNAR NERVE NEUROPATHY, ONE FROM EACH GROUP. TWO (2) PATIENTS IN GROUP II HAD HETEROTOPIC OSSIFICATION, WITH ONE (1) PATIENT UNDERGOING RESECTION WITH ELBOW CONTRACTURE RELEASE 3 MONTHS POSTOPERATIVELY. FIVE (5) PATIENTS IN GROUP I AND 6 PATIENTS IN GROUP II REQUESTED HARDWARE REMOVAL. ELEVEN (11) PATIENTS IN GROUP I RECOVERED FULL ARC OF FLEXION AND 13 PATIENTS IN GROUP II ACHIEVED FULL ARC OF FLEXION. ALL PATIENTS OBTAINED BONE UNION, EXCEPT 2 PATIENTS IN GROUP I. NO SIGNIFICANT DIFFERENCES WERE FOUND BETWEEN THE CLINICAL OUTCOMES OF THE 2 PLATING METHODS. THE AUTHORS CONCLUDED THAT FROM A CLINICAL PERSPECTIVE, A PARALLEL PLATING METHOD APPEARS TO BETTER PROVIDE RIGID FIXATION THAT IS ADEQUATE FOR OBTAINING BONE UNION. HOWEVER, NO SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN THE ORTHOGONAL AND PARALLEL DOUBLE PLATING METHODS IN TERMS OF CLINICAL OUTCOMES AND COMPLICATION RATES. IF APPROPRIATELY APPLIED WITH SUITABLE PLATES, BOTH PARALLEL AND ORTHOGONAL POSITIONING CAN PROVIDE ADEQUATE STABILITY AND ANATOMIC RECONSTRUCTION OF THE DISTAL HUMERUS FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955431 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other