BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 INTERNAL CAPTURE

    MDR report key: 2200558 · Received August 11, 2011

    Report

    Report Number
    1020279-2011-00311
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    August 10, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAE REPORTED DUE TO A FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0 INTERNAL CAPTURE INT HEX SCR 5.0MM X 20MM HWC SMITH & NEPHEW, INC. 71642220 08CT18244

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R PRODUCT # 71642220 LOT # 07BM01859| PRODUCT # 71856000 LOT # 10BM00614| PRODUCT # 71642270 LOT # 09GM09883| PRODUCT # 71642240 LOT # 10AM06413| PRODUCT # 71701020 LOT # 08EM18101