SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE
Received Apr 29, 2013 · Event occurred Nov 17, 2011
Report 8030965-2013-11192 · MDR key 3081838
Device
Product problems
- Device Operates Differently Than Expected
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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).
Additional Manufacturer Narrative
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
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.