BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACU-LOC VOLAR WRIST PLATING SYSTEM

    MDR report key: 5246934 · Received November 24, 2015

    Report

    Report Number
    3025141-2015-00182
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Report Date
    January 26, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2015-00180: PLATE 1, 3025141-2015-00181: PLATE 2, 3025141-2015-00183: PLATE 4, 3025141-2015-00184: PLATE 5, 3025141-2015-00185: PLATE 6, 3025141-2015-00186: PLATE 7, 3025141-2015-00187: PLATE 8, 3025141-2015-00188: PLATE 9, 3025141-2015-00189: PLATE 10, 3025141-2015-00190: PLATE 11, 3025141-2015-00191: PLATE 12, 3025141-2015-00192: PLATE 13, 3025141-2015-00193: PLATE 14, 3025141-2015-00194: PLATE 15, 3025141-2015-00195: PLATE 16, 3025141-2015-00196: PLATE 17, 3025141-2015-00197: PLATE 18, 3025141-2015-00198: PLATE 19, 3025141-2015-00199: PLATE 20, 3025141-2015-00200: PLATE 21, 3025141-2015-00201: PLATE 22, 3025141-2015-00202: PLATE 23, 3025141-2015-00203: PLATE 24, 3025141-2015-00204: PLATE 25, 3025141-2015-00205: PLATE 26, 3025141-2015-00206: PLATE 27, 3025141-2015-00207: PLATE 28.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2015-00180 FOLLOW UP 1: PLATE 1, 3025141-2015-00181 FOLLOW UP 1: PLATE 2, 3025141-2015-00183 FOLLOW UP 1: PLATE 4, 3025141-2015-00184 FOLLOW UP 1: PLATE 5, 3025141-2015-00185 FOLLOW UP 1: PLATE 6, 3025141-2015-00186 FOLLOW UP 1: PLATE 7, 3025141-2015-00187 FOLLOW UP 1: PLATE 8, 3025141-2015-00188 FOLLOW UP 1: PLATE 9, 3025141-2015-00189 FOLLOW UP 1: PLATE 10, 3025141-2015-00190 FOLLOW UP 1: PLATE 11, 3025141-2015-00191 FOLLOW UP 1: PLATE 12, 3025141-2015-00192 FOLLOW UP 1: PLATE 13, 3025141-2015-00193 FOLLOW UP 1: PLATE 14, 3025141-2015-00194 FOLLOW UP 1: PLATE 15, 3025141-2015-00195 FOLLOW UP 1: PLATE 16, 3025141-2015-00196 FOLLOW UP 1: PLATE 17, 3025141-2015-00197 FOLLOW UP 1: PLATE 18, 3025141-2015-00198 FOLLOW UP 1: PLATE 19, 3025141-2015-00199 FOLLOW UP 1: PLATE 20, 3025141-2015-00200 FOLLOW UP 1: PLATE 21, 3025141-2015-00201 FOLLOW UP 1: PLATE 22, 3025141-2015-00202 FOLLOW UP 1: PLATE 23, 3025141-2015-00203 FOLLOW UP 1: PLATE 24, 3025141-2015-00204 FOLLOW UP 1: PLATE 25, 3025141-2015-00205 FOLLOW UP 1: PLATE 26, 3025141-2015-00206 FOLLOW UP 1: PLATE 27, 3025141-2015-00207 FOLLOW UP 1: PLATE 28, 3025141-2018-00020: PLATE 29, 3025141-2018-00021: PLATE 30, 3025141-2018-00022: PLATE 31, 3025141-2018-00023: PLATE 32, 3025141-2018-00024: PLATE 33, 3025141-2018-00025: PLATE 34, 3025141-2018-00026: PLATE 35, 3025141-2018-00027: PLATE 36.

    Description of Event or Problem · 1

    A WEB ABSTRACT (HTTP://WWW.AOTT.ORG.TR/ARTICLE/VIEW/5000140554) DOCUMENTS A NEW COMPLICATION IN VOLAR LOCKING PLATING OF DISTAL RADIUS. BETWEEN JANUARY 2007 AND 2014, 223 PATIENTS WITH RETROSPECTIVE CHART AND RADIOGRAPHIC REVIEWS WERE IDENTIFIED FOR THIS STUDY. OF THE 223 PATIENTS, 28 EXPERIENCED LONGITUDINAL FRACTURE LINES BENEATH ACU-LOC WRIST VOLAR PLATE (USING LOCKING SCREWS) EXTENDING ALONG THE PROXIMAL SHAFTS. THE 28 CASES WERE ALL PATIENTS OVER THE AGE OF 60 YEARS. CONCLUSION DRAWN BY AUTHORS OF THE ABSTRACT: BY AGING, THINNING AND WEAKENING NEAR CORTEX MAY BE MORE BRITTLE. WHEN THE PLATE IS REDUCED ON THE BONE WITH A NONLOCKING SCREW, THE CONICAL HEAD OF DIAPHYSEAL LOCKING SCREWS CAN INSERT INTO NEAR CORTEX BELOW THE PLATE, ACTING AS A SCREWING WEDGE.

    Description of Event or Problem · 1

    CASE 3: FEMALE, >(B)(6) YEARS OLD, EXPERIENCED A LONGITUDINAL FRACTURE WHEN PLATED WITH AN ACU-LOC PLATE. ORIGINAL MDR FILED BASED ON ABSTRACT OF ARTICLE. FULL ARTICLE IS NOW AVAILABLE: "A NEW COMPLICATION IN VOLAR LOCKING PLATING OF THE DISTAL RADIUS: LONGITUDINAL FRACTURES OF THE NEAR CORTEX." TAHHIR SADIK SUGUN, YUSUF GURBUZ, KEMAL OZAKSAR, TULGAR TOROS, EMIN BAL, MURAT KAYALAR. ACTA ORTHOP TRAUMATOL TURC 2016; 50(2): 147-152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777027 ACU-LOC VOLAR WRIST PLATING SYSTEM PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1