BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2901336 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00150
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM A DISTAL HUMERUS FRACTURE AND WAS IMPLANTED WITH TWO DISTAL HUMERUS PLATES, AN OLECRANON PLATE PROXIMAL ULNAR, AND SCREW CONSTRUCT ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, PATIENT SUFFERED FROM AN INFECTION AT IMPLANT SITE. ON (B)(6) 2012 PATIENT RETURNED TO THE OPERATING ROOM AND ALL THREE PLATES WERE REMOVED, INCLUDING 21 SCREWS. ALL HARDWARE WAS REMOVED WITHOUT ANY PROBLEMS. THIS IS 12 OF 24 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8620 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATES, SCREWS