BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04029

    MDR report key: 3202499 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04029
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 2.7MM/3.5MM A VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) OLECRANON PLATE AND SCREW CONSTRUCT ON (B)(6) 2013. CLINICAL FINDINGS NOTED THE PATIENT HAD A DELAYED HEALING. THE PATIENT PRESENTED WITH NON-UNION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE REPORTEDLY DUE TO FAILURE OF FIXATION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATION. REPORTEDLY THERE IS NO ANTICIPATED TREATMENT AT THIS TIME. THIS REPORT IS FOR FOUR (4) UNKNOWN 2.7MM VA LOCKING SCREW - 02.211.0XX PART FAMILY. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302216 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention