BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04498

    MDR report key: 3233789 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04498
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP DR). POST OPERATIVELY, THE PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME. PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE PER CHECKUP ON (B)(6) 2012. THIS REPORT IS FOR AN UNKNOWN VA LCP PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336344 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR