BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03679

    MDR report key: 3183657 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03679
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    September 13, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICES WERE NOT RETURNED FOR INSPECTION. AN INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN ROD WHERE IT WAS REPORTED THAT THE ROD COULD NOT BE PLACED AS THE INNER PART WAS ROTATED. THE SURGEON WANTED TO ALIGN THE TULIPS AND THE INNER GOLDEN PIECE OF THE ROD WAS ROTATED IN THE TULIP SO THE ROD COULD NOT BE PLACED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284449 HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1