BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 18MM LOCKING CORTICAL SCREW

    MDR report key: 3942443 · Received July 17, 2014

    Report

    Report Number
    3025141-2014-00172
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT:MDR 3025141-2014-00164: PLATEMDR 3025141-2014-00165: SCREW 1MDR 3025141-2014-00166: SCREW 2MDR 3025141-2014-00167: SCREW 3MDR 3025141-2014-00168: SCREW 4MDR 3025141-2014-00169: SCREW 5MDR 3025141-2014-00170: SCREW 6MDR 3025141-2014-00171: SCREW 7MDR 3025141-2014-00173: SCREW 9MDR 3025141-2014-00174: SCREW 10

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SCREW WAS PERFORMED. THE HEAD OF THE SCREW WAS BROKEN OFF AND WAS NOT RETURNED TO ACUMED. THE FRACTURE SITE APPEARS TO BE A TORSIONAL FAILURE. THE CAUSE OF THE BREAKAGE CANNOT BE CONCLUSIVELY DETERMINED. CONCLUSION - A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFORMATION CONCERNING THE CIRCUMSTANCES OF THIS PLATE BREAKAGE. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00164 FOLLOW UP 1: PLATE 1; MDR 3025141-2014-00165 FOLLOW UP 1: SCREW 1; MDR 3025141-2014-00166 FOLLOW UP 1: SCREW 2; MDR 3025141-2014-00167 FOLLOW UP 1: SCREW 3; MDR 3025141-2014-00168 FOLLOW UP 1: SCREW 4; MDR 3025141-2014-00169 FOLLOW UP 1: SCREW 5; MDR 3025141-2014-00170 FOLLOW UP 1: SCREW 6; MDR 3025141-2014-00171 FOLLOW UP 1: SCREW 7; MDR 3025141-2014-00173 FOLLOW UP 1: SCREW 9; MDR 3025141-2014-00174 FOLLOW UP 1: SCREW 10 MDR 3025141-2014-00195: PLATE 2; MDR 3025141-2014-00196: SCREW 11.

    Description of Event or Problem · 1

    AN IMPLANTED VOLAR DISTAL RADIUS PLATE BROKE POST OPERATIVELY AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419309 2.3MM X 18MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HRS ACUMED LLC CO-T2318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention