BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCER

    MDR report key: 3070073 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10729
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE RELEASE KNOB AND PART OF THE CAPTURE PIN WERE NOT PRESENT. THE REMAINDER OF THE BROKEN CAPTURE PIN SHOWS NO VISIBLE MECHANICAL DEFECTS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE EVALUATION PERFORMED, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    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. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLF AT 3-4 AND 4-5. THE SURGEON IMPLANTED THE ROD AND ONCE THE ROD WAS IN PLACE, THE RELEASE BUTTON ON THE ROD INTRODUCER BROKE OFF. THE SURGEON WAS UNABLE TO RELEASE THE ROD FROM THE INTRODUCER. ROD WAS EXPLANTED AND A NEW ROD IMPLANTED USING A DIFFERENT INTRODUCER. 15 MINUTES WAS ADDED TO THE PROCEDURE. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM AND NO HARM TO PATIENT. ROD IS STILL ATTACHED TO ROD INTRODUCER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171872 ROD INTRODUCER LXH SYNTHES MONUMENT 6669094

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR