BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES INC.

    MDR report key: 5107163 · Received December 30, 2004

    Report

    Report Number
    5107163
    Event Type
    Injury
    Date Received
    December 30, 2004
    Date of Event
    November 4, 2004
    Report Date
    November 16, 2004
    Manufacturer
    SYNTHES, INC.
    Product Code
    JDP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2004, PT HAD PLATE IMPLANTED IN RIGHT RADIAL ARM FOR FRACTURE. ON (B)(6) 2004, PT WAS SCHEDULED FOR ORIF OF RIGHT ARM TO REMOVE HARDWARE PLATE THAT WAS BROKEN IN PT'S ARM. PT ALSO INDICATED THAT HE FELL OVER A 2X4 AND HE BROKE HIS ARM AGAIN. REF MFR #1719045-2004-00097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES INC. 35 MM 7-HOLE LCP RECONSTRUCTION JDP SYNTHES, INC. 245-071

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other