BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 18095468 · Received November 8, 2023

    Report

    Report Number
    3025141-2023-00618
    Event Type
    Injury
    Date Received
    November 8, 2023
    Report Date
    November 3, 2023
    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

    IN A PREPRINT (NOT PEER REVIEWED) ARTICLE " EFFECT OF INTRAOPERATIVE HAND-GRIP POSITION ON SURGICAL OUTCOME OF THUMB CARPOMETACARPAL ARTHRODESIS" BY ALVIN, K.A., ET AL, THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW AIMED TO EVALUATE THE EFFICACY OF OUR INTRAOPERATIVE HAND-GRIP POSITIONING METHOD FOR ARTHRODESIS OF THUMB CARPOMETACARPAL JOINT (CMCJ) OSTEOARTHRITIS (OA). 20 PATIENTS WITH CMCJ OA UNDERWENT ARTHRODESIS USING THEIR INTRAOPERATIVE HAND-GRIP POSITIONING METHOD AND T-HOOK PLATES AND SCREWS (ACUMED LLC, USA). PATIENTS WERE EVALUATED PREOPERATIVELY AND AT 1, 3, 6 AND 12 MONTHS POSTOPERATIVELY. RADIOLOGIC ASSESSMENT INCLUDING FUSION EVALUATION, EVALUATION OF RADIAL AND PALMAR ABDUCTION ANGLES WAS DONE ON HAND X-RAYS. THE AUTHORS ALSO PERFORMED A LITERATURE REVIEW TO UNDERSTAND THE CURRENT TRENDS AND TECHNIQUES OF ARTHRODESIS FOR COMPARISON. 20 PATIENTS WITH A MINIMUM FOLLOW-UP DURATION OF 12 MONTHS WERE INCLUDED IN THIS STUDY. 100% FUSION RATE WAS ACHIEVED WITH ONLY 1 CASE OF COMPLICATION INVOLVING RADIAL SENSORY NERVE NEUROPATHY WHICH WAS RESOLVED AFTER REMOVAL OF IMPLANT AND NEUROLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744082 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other