InjuryOUR
VYRSA SI JOINT IMPLANT
Received Nov 8, 2022 · Event occurred Dec 14, 2021
Report MW5113172 · MDR key 15760372
Device
Generic name
Sacroiliac Joint Fixation
Manufacturer
Vyrsa TechnologiesProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
41 YR · Female
- Pain
- Pain
Narrative
Description of Event or Problem
I HAD A SURGERY THAT USED THE VYRSA SI JOINT IMPLANT TO CREATE A SACROILIAC FUSION. IT IS AN IMPLANT THAT IS PLACED IN THE SI JOINT. I HAVE HAD SIGNIFICANT INCREASED PAIN AND SYMPTOMS AND MORE SEVERE DISABILITY SINCE MY SURGERY. I HAVE ALSO HAD NEW SYMPTOMS SINCE THE IMPLANT PLACEMENT THAT WERE NOT THERE BEFORE THE SURGERY. OVERALL, THE SURGERY FAILED TO RESOLVE MY PREVIOUS ISSUE AND CREATED NEW PROBLEMS. AND I WILL REQUIRE ANOTHER SI SURGERY BUT IT WONT BE ABLE TO CORRECT THE NEW SYMPTOMS/PROBLEMS THAT THE IMPLANT HAS CAUSED. FDA SAFETY REPORT ID# (B)(4).