MYSPINE S2-SI LEFT GUIDE

Additional Manufacturer Narrative

MYSPINE PROJECT MANAGER ANALYSIS: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE ALSO REPRINTED THE GUIDES AND BONE MODEL IN ORDER TO CHECK THE FITTING AGAIN; THE RESULT IS CONFORM WITHOUT ANY KIND OF DOUBT.

Description of Event or Problem

AFTER THE SURGEON HAD DRILLED THE PILOT HOLES, AND PLACED THE SCREWS, IT WAS OBSERVED THAT THE LAST 4 SCREWS WERE INACCURATE WITH THE MYSPINE GUIDES. TO COMPLETE THE CASE, THE SURGEON USED A THORACIC PROBE AND MANIPULATED THE TRAJECTORY, TOOK X-RAYS, PUT A GUIDEWIRE DOWN, AND WENT THROUGH THE PROCESS OF PLACING THE SCREWS. THERE WAS A 30-MINUTESOF DELAY ON A SURGERY OF 3 HOURS AND THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT ADDITIONAL ANESTHESIA WAS NECESSARY.

Additional Manufacturer Narrative

VISUAL INSPECTION PERFORMED BY MYSOLUTION DEPARTMENT: WE CHECKED ALL THE GUIDES DESIGNED FOR THE SACRUM (S01, S02-SI LEFT AND RIGHT). THE RESULT OF THE FITTING AND THE FUNCTIONAL CHECK IS CONFORM, THE GUIDES ARE GOOD AND STABLE WITHOUT ANY PROBLEM.