BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN

    MDR report key: 2864753 · Received December 10, 2012

    Report

    Report Number
    1020279-2012-00670
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTAN 11.5MM X 36CM 125D LT JDS SMITH & NEPHEW, INC. 07BM00864

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) INT HEX CAP SCR 5.0MM X 35MM (B)(4)| (B)(4) LAG/COMP SCREW KIT 90/85 (B)(4)| (B)(4) INT HEX CAP SCR 5.0MM X 40MM (B)(4)