BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE IMPLANT

    MDR report key: 2793445 · Received October 17, 2012

    Report

    Report Number
    2520274-2012-02304
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Report Date
    September 18, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SPINAL IMPLANT ON (B)(6) 2011. REPORTEDLY, THE PATIENT HAS BEEN HAVING AN ONGOING RASH AND IS NOT SURE WHAT IS CAUSING THE RASH. THE PATIENT IS SEEING AN ALLERGIST. UNSURE IF THE RASH IS CAUSE BY THE SPINAL IMPLANT IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE IMPLANT SPINE IMPLANT KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1