BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 22500465 · Received July 14, 2025

    Report

    Report Number
    3025141-2025-00273
    Event Type
    Injury
    Date Received
    July 14, 2025
    Report Date
    July 14, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    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 (4 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00270, 3025141-2025-00271, 3025141-2025-00272.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARTICLE CITED, "WÆVER D, THORNINGER R, ROMME KL, TJØRNILD M, RÖLFING JD. POST-TRAUMATIC OSTEOARTHRITIS AND FUNCTIONAL OUTCOMES AFTER VOLAR PLATING VS. CASTING OF UNSTABLE DISTAL RADIUS FRACTURES: A MINIMUM 2-YEAR FOLLOW-UP OF THE VOLCON RANDOMIZED CONTROLLED TRIAL. JOURNAL OF CLINICAL MEDICINE. 2025 MAY;14(11):3766. DOI: 10.3390/JCM14113766. PMID: 40507528; PMCID: PMC12155583." THIS PROSPECTIVE STUDY IS A CONTINUATION OF THE VOLCON RANDOMIZED CONTROLLED TRIAL AND REVIEWED PATIENTS TREATED BETWEEN NOVEMBER 2019 AND MARCH 2022. THIS STUDY DESCRIBES THE MINIMUM 2-YEAR FOLLOW-UP OF THE PUBLISHED VOLCON PROSPECTIVE, SINGLE-CENTER, ASSESSOR-BLINDED, RANDOMIZED, CONTROLLED SUPERIORITY TRIAL THAT COMPARED NON-OPERATIVE VERSUS OPERATIVE TREATMENTS OF UNSTABLE DRFS IN PATIENTS 65 YEARS OR OLDER. ACCORDING TO SAMPLE SIZE CALCULATIONS FROM THE PRIMARY STUDY, 100 PATIENTS WERE INCLUDED, AND ALL PATIENTS WERE BLINDLY RANDOMIZED INTO EITHER AN "OPERATIVE" OR "NON-OPERATIVE" TREATMENT GROUP. PATIENTS ALLOCATED TO OPERATIVE GROUP WERE TREATED WITH ORIF WITH VOLAR LOCKING PLATE FIXATION (ACU-LOC, ACUMED, HILLSBORO, OR, USA OR VARIAX, STRYKER, KALAMAZOO, MI, USA). IT WAS NOT STATED HOW MANY PATIENTS WERE TREATED WITH WHICH PLATING SYSTEM. ALL PATIENTS WERE OPERATED ON USING A STANDARD HENRY APPROACH FOR THE DISTAL RADIUS. THE REPAIR OF THE PRONATOR QUADRATUS WAS PERFORMED WHEN POSSIBLE. PATIENTS WERE OPERATED UNDER REGIONAL OR GENERAL ANESTHESIA. POST-OPERATIVELY, THE WRIST WAS IMMOBILIZED WITH A DORSAL PLASTER CAST FOR 2 WEEKS, FOLLOWED BY 3 WEEKS OF IMMOBILIZATION WITH A REMOVABLE WRIST ORTHOSIS. A SINGLE SESSION OF HAND THERAPY INSTRUCTION TOOK PLACE. PATIENTS ALLOCATED TO THE NON-OPERATIVE TREATMENT GROUP WERE IMMOBILIZED WITH A DORSAL PLASTER CAST FOR 5 WEEKS. A SINGLE SESSION OF HAND THERAPY INSTRUCTION TOOK PLACE AFTER CAST REMOVAL. NO RADIOGRAPHS WERE PERFORMED BEFORE THE 5-WEEK FOLLOW-UP. IN THIS MINIMUM 2-YEAR FOLLOW-UP OF AN RCT INVESTIGATING OPERATIVE VERSUS NON-OPERATIVE TREATMENTS OF DISPLACED DRFS IN PATIENTS 65 YEARS OR OLDER, NO CORRELATION BETWEEN TREATMENT CHOICE AND THE DEVELOPMENT OF POST-TRAUMATIC OA WAS FOUND. FURTHERMORE, THERE WERE NO DIFFERENCES IN QUICK-DASH, PRWHE, THE PAIN SCORE, ROM, OR GRIP STRENGTH AT THE 2-YEAR FOLLOW-UP BETWEEN THE TWO TREATMENT GROUPS. AS EXPECTED, THERE WAS SIGNIFICANTLY GREATER DORSAL ANGULATION IN THE NON-OPERATIVE GROUP. IMPLANT-RELATED COMPLICATIONS SUCH AS SCREW LOOSENING AND PLATE REMOVAL DUE TO PROTRUDING SCREWS CAUSING TENDON IRRITATION WERE OBSERVED BETWEEN 1 AND 2 YEARS. IN THE OPERATIVE GROUP, TWO ADDITIONAL SURGERIES WERE PERFORMED BETWEEN THE 1- AND 2-YEAR FOLLOW-UPS: ONE PLATE WAS REMOVED DUE TO EXTENSOR TENDON IRRITATION, AND ONE PATIENT UNDERWENT WRIST ARTHRODESIS. FURTHERMORE, ONE PROXIMAL SCREW LOOSENED BUT WAS NOT REMOVED, AND ONE PATIENT HAD BROKEN SCREWS; HOWEVER, THE BONE HEALED WITH INCREASED DORSAL ANGULATION WITHOUT REQUIRING REOPERATION. THE AUTHORS CONCLUDED THIS STUDY FOUND NO DIFFERENCE IN POST-TRAUMATIC OA OR FUNCTIONAL OUTCOMES BETWEEN OPERATIVELY OR NON-OPERATIVELY TREATED DISPLACED DRFS IN ELDERLY PATIENTS 65 YEARS OR OLDER AFTER 2 YEARS OF FOLLOW-UP. THIS ADDS TO THE COMPILING EVIDENCE THAT THE CHOICE OF TREATMENT CONTRIBUTES LITTLE TO THE VARIABILITY IN FUNCTIONAL AND RADIOLOGICAL OUTCOMES AFTER DRFS. HOWEVER, LONGER FOLLOW-UP STUDIES ARE WARRANTED TO BETTER ASSESS THE DETECTION OF POST-TRAUMATIC OA AS THIS STUDY CONTRIBUTES TO HIGHLIGHT SHORT- TO MEDIUM-TERM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400877 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other