BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3763948 · Received March 20, 2014

    Report

    Report Number
    3025141-2014-00033
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2014-00032: 70-0315 PLATE; 3025141-2014-00034: SCREW 2; 3025141-2014-00035: SCREW 3; 3025141-2014-00036: SCREW 4; 3025141-2014-00037: SCREW 5; 3025141-2014-00038: SCREW 6; 3025141-2014-00039: SCREW 7; 3025141-2014-00040: SCREW 8; 3025141-2014-00041: SCREW 9; 3025141-2014-00042: SCREW 10; 3025141-2014-00043: SCREW 11; 3025141-2014-00044: SCREW 12; 3025141-2014-00045: SCREW 13.

    Description of Event or Problem · 1

    AN OLECRANON PLATE WAS IMPLANTED ON (B)(6) 2013. ON (B)(6) 2014, THE PATIENT REPORTED PAIN TO THE DOCTOR. THE PLATE WAS BROKEN AT THE LEVEL OF THE NON UNION AND WAS EXPLANTED, ALONG WITH 13 SCREWS, ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165310 SCREW, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention