BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM X 16.0MM LOCKING CORTICAL SCREW

    MDR report key: 4180858 · Received October 17, 2014

    Report

    Report Number
    3025141-2014-00239
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS EXAMINED UNDER MAGNIFICATION. THE SCREW WAS ALMOST COMPLETELY BROKEN WHERE THE TAPERED PORTION OF THE THREADS TRANSITIONS TO THE STRAIGHT SEGMENT OF THE SCREW. CONCLUSION - A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFORMATION CONCERNING THE CIRCUMSTANCES OF THIS SCREW BREAK.ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT:MDR 3025141-2014-00233: PLATE,MDR 3025141-2014-00234: SCREW 1,MDR 3025141-2014-00235: SCREW 2,MDR 3025141-2014-00236: SCREW 3,MDR 3025141-2014-00237: SCREW 4,MDR 3025141-2014-00238: SCREW 5.

    Description of Event or Problem · 1

    THE PATIENT WAS INVLOVED IN A MOTORCYLCE ACCIDENT AND FRACTURED HIS CLAVICLE. A CLAVICLE PLATE WAS IMPLANTED. FOUR WEEKS LATER, TWO OF THE SIX SCREWS WERE BROKEN. THE PLATE AND ALL SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663177 2.7MM X 16.0MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HRS ACUMED LLC COL-2160 232296

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention