BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN 10S

    MDR report key: 3870233 · Received June 12, 2014

    Report

    Report Number
    1020279-2014-00365
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    .

    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
    347657 INTERTAN 10S 11.5MM X 34CM 125D LT JDS SMITH & NEPHEW, INC. 11DM16549

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R 71642245 INT HEX CAP SCR 5.0MM X 45MM LOT 12JM0547| 71677095 LAG/COMP SCREW KIT 95/90 LOT 13HT33594