VYRSA-N1 SI FUSION SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT ONE WEEK POST OP FROM THE IMPLANTATION OF A VYRSA N1 SACROILIAC FIXATION DEVICE , THE PATIENT WAS UNABLE TO WALK OR PUT ANY PRESSURE ON THE LEFT LEG. THE PATIENT WENT TO THE EMERGENCY ROOM, AND A CT SCAN WAS PERFORMED. THE SCAN SHOWED A LARGE AMOUNT OF EDEMA AROUND THE SCIATIC NERVE. THE SURGEON SAID THIS IS A COMMON OCCURRENCE, SINCE THE PATIENT HAS STENOSIS ON THE LUMBAR SPINE. THE PATIENT WAS PRESCRIBED INCREASED PAIN MEDICATION, TIZANIDINE FOR THREE WEEKS, AND TEN DAYS OF BED REST. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

Additional Manufacturer Narrative

VYRSA SUBMITS THIS REPORT IN COMPLIANCE WITH FDA'S MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803. VYRSA HAS COMPLIED WITH REGULATORY INVESTIGATION REQUIREMENTS AND IS SUBMITTING ALL INFORMATION THAT IS REASONABLY KNOWN TO US AT THIS TIME. HOWEVER, WE MAY NOT HAVE BEEN ABLE TO CONFIRM THIS INFORMATION OR COMPLETE THE INVESTIGATION WITHIN THE TIMEFRAME FOR FILING THIS REPORT. WE MAY HAVE GIVEN NO RESPONSE OR AN INCOMPLETE RESPONSE TO CERTAIN QUESTIONS BECAUSE WE DO NOT CURRENTLY HAVE INFORMATION AVAILABLE TO PROVIDE A COMPLETE RESPONSE. IF WE LATER OBTAIN ANY REQUIRED INFORMATION THAT WAS NOT AVAILABLE AT THE TIME OF THIS INITIAL REPORT, WE WILL SUBMIT A SUPPLEMENTAL REPORT. THIS REPORT IS NOT AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT WAS DEFECTIVE, THAT IT MALFUNCTIONED, OR THAT IT CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. WE MAY CONCLUDE THAT THE DEVICE HAD NO DEFECT, DID NOT MALFUNCTION, OR DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE EVENT. SOME OF THE ITEMS ON THIS FORM INCLUDE FORCED-CHOICE TERMS USED BY THE FDA FOR REPORTING PURPOSES THAT DO NOT NECESSARILY REFLECT VYRSA'S CONCLUSIONS ABOUT THE CAUSES OR NATURE OF THE EVENT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY FREEDOM OF INFORMATION ACT RESPONSE.