BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 INTERNAL CAPTURE

    MDR report key: 2974772 · Received February 22, 2013

    Report

    Report Number
    8010764-2013-00013
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING DISTAL INSERTION OF THE SCREW, THE PATIENT'S BONE WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78637 5.0 INTERNAL CAPTURE INT HEX CAP SCR 5.0MM X 30MM HWC SMITH & NEPHEW, INC. 12HT22250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) LOT 12LT25118| (B)(4) LOT 12HT22202| (B)(4) LOT 12KM18562