BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02341

    MDR report key: 3091616 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02341
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH THE LCP ALDTP AND LAG SCREW FOR A RIGHT TIBIA SHAFT FRACTURE. A PTB BRACE WAS APPLIED ON (B)(6) 2012. ON (B)(6) 2013, THE SURGEON FOUND METAL BROKEN THROUGH X-RAY. THE SURGEON REMOVED THE BROKEN PLATE AND INSERTED A NAIL ON (B)(6) 2013. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194908 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention