BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR HANDLE

    MDR report key: 3052095 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10778
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORACLE PROCEDURE, ACCORDING TO THE SURGEON, THE MEDIUM AND LARGE ADJACENT DILATORS WERE AUTO ROTATING ADDING TIME TO THE PROCEDURE. ALSO THE SURGEON CAN SEE MORE RADIOLUCENCY IN THE NEW ONES. THE RETRACTOR HANDLE WAS PLACED DIRECTLY OVER A NERVE AND PENETRATED THE DISC SPACE WITH NO HARM TO THE PATIENT. SURGEON DID NOT REPOSITION THE RETRACTOR. THE QUICK RELEASE T-HANDLE WAS USED WITH THE ORACLE TRIALS AND WERE STICKING TO THE HANDLE. THE SURGEON WAS PLEASED WITH THE COMPLETED PROCEDURE. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 4 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155451 RETRACTOR HANDLE GAD SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1