BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE

    MDR report key: 3081838 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11192
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 17, 2011
    Report Date
    November 17, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    OMR
    PMA / PMN Number
    K103558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: DURING AN ANTERIOR LUMBAR INTERBODY FUSION (L4-S1) PROCEDURE, THE CORNER OF THE SCOUT VESSEL GUARD RIPPED AFTER THE SUTURE WAS PLACED. THE OTHER THREE (3) CORNERS WERE OKAY. SURGEON LEFT THE SCOUT VESSEL GUARD IN PLACE. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184885 SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE OMR SYNTHES (USA) N002929

    Patients

    Seq Age Sex Outcome Treatment
    1