BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11055

    MDR report key: 3032165 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-11055
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    October 27, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC COAT IS PEELING AND THERE IS RUST PRESENT ON THE GRAPHIC CASE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PART AND LOT NUMBER FOR A GRAPHIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137177 FSM SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1