VYRSA-NEVRO1 SI FUSION SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NEVRO1 DEVICE ON (B)(6) 2024. THE DOCTOR WAS MADE AWARE ON 12/16/2024 THAT THE PATIENT WAS DIAGNOSED WITH OSTEOMYELITIS. THE DOCTOR PLACED A PIC LINE TO BEGIN ANTIBIOTIC TREATMENT.

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.

Additional Manufacturer Narrative

UPDATED SECTIONS: B5, D6B., H6 CODE FOR HEALTH EFFECT - IMPACT CODE, THE OTHER CODES IN H6 REMAIN UNCHANGED FROM THE PREVIOUS SUBMITTED FORM. NEVRO SUBMITS THIS REPORT IN COMPLIANCE WITH FDA¿S MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803. NEVRO 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 NEVRO¿S CONCLUSIONS ABOUT THE CAUSES OR NATURE OF THE EVENT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY FREEDOM OF INFORMATION ACT RESPONSE.

Description of Event or Problem

ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS EXPLANTED. THE DOCTOR INDICATED THAT THE REASON FOR THE INFECTION WAS NOT RELATED TO THE DEVICE, BUT RATHER DUE TO THE PATIENT'S HYGIENE HABITS. DOCTOR REPORTED THAT SPECIMEN REPORT SHOWED E. COLI BEING THE CAUSE OF INFECTION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.