SIROS-O

Additional Manufacturer Narrative

THE PATIENT HAD BOTH OF HER SI JOINTS FUSED IN TWO SEPARATE PROCEDURES. ONE SURGERY, PERFORMED (B)(6) 2025, TREATED THE PATIENT'S RIGHT SIDE AND THE SECOND SURGERY WAS PERFORMED (B)(6) 2025 TO TREAT HER LEFT SIDE. TWO TITANIUM ALLOY IMPLANTS WERE PLACED, USING AN OBLIQUE TRAJECTORY, IN EACH SI JOINT. THE IMPLANTS ARE MADE FROM MEDICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI). A ROUTINE FOLLOW-UP VISIT AND CT SCAN WAS PERFORMED IN LATE (B)(6) 2025. THE RESULTS SHOWED "SURGICAL SCREW IMPLANTS IN BOTH SI JOINTS APPEAR TO BE ADEQUATELY POSITIONED". HOWEVER, THE PHYSICIAN REPORTED THAT NO FUSION HAD OCCURRED AT THAT TIME. IF FUSION STILL HAS NOT OCCURRED, IT COULD BE THE CAUSE, OR A CONTRIBUTING FACTOR, OF THE PATIENT'S SYMPTOMS. SOMETIME AFTER (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING LOWER BACK PAIN AND UPPER BUTTOCK PAIN AROUND THE INCISION SITE. SHE BEGAN SEEING ANOTHER PAIN MANAGEMENT PHYSICIAN AND SHE RECENTLY HAD A LUMBAR RADIOFREQUENCY ABLATION PERFORMED. THIS PRODUCED VERY LITTLE REDUCTION IN HER PAIN. THE PAIN MANAGEMENT PHYSICIAN WAS REPORTEDLY DOING STEROID BASED INJECTIONS AS WELL AS MEDICATION (ADDITIONAL DETAILS WERE NOT PROVIDED). DURING THE PATIENT'S LAST OFFICE VISIT (B)(6) 2026) WITH THE PHYSICIAN THAT SURGICALLY TREATED HER SI JOINTS, THE PATIENT EXPRESSED CONCERN THAT SHE MAY BE ALLERGIC TO THE TITANIUM IMPLANTS. DURING THE VISIT, AN UPDATED MRI OF THE LUMBAR SPINE WAS ORDERED, AND THE PATIENT WAS REFERRED TO AN ALLERGY SPECIALIST. AS OF (B)(6) 2026, THE PATIENT HAD NOT HAD THE IMAGING PERFORMED. THE PATIENT WAS SCHEDULED TO SEE THE ALLERGY SPECIALIST ON MONDAY (B)(6) 2026) BUT NO FOLLOW UP INFORMATION HAS BEEN PROVIDED. INVESTIGATION OF THE IMPLANTS / MANUFACTURING LOTS DETERMINED THE IMPLANTS WERE PROPERLY DESIGNED AND MANUFACTURED. NO DEVICE PROBLEM WAS FOUND. THE PATIENT'S PAIN APPEARS TO BE ATTRIBUTED TO EITHER A LACK OF FUSION IN ONE OR BOTH SI JOINTS, OR THE PATIENT IS ALLERGIC TO TITANIUM ALLOY. BASED ON THE CURRENT INFORMATION, THIS ISSUE IS CATEGORIZED AS AN ADVERSE EVENT WITHOUT AN IDENTIFIED DEVICE OR USE PROBLEM.

Description of Event or Problem

THE PATIENT HAD TWO SI JOINT FUSION SURGERIES: HER RIGHT SIDE WAS TREATED ON (B)(6) 2025 AND HER LEFT SIDE WAS TREATED ON (B)(6) 2025. DURING A ROUTINE FOLLOW UP AND CT SCAN, PERFORMED (B)(6) 2025, THE PATIENT HAD NOT FUSED IN EITHER SI JOINT. SOMETIME THEREAFTER, THE PATIENT BEGAN EXPERIENCING LOWER BACK PAIN AND UPPER BUTTOCK PAIN AROUND THE INCISION SITE. SHE BEGAN SEEING A PAIN MANAGEMENT PHYSICIAN. THE PAIN MANAGEMENT PHYSICIAN PERFORMED A LUMBAR RADIOFREQUENCY ABLATION WHICH PRODUCED MINIMAL REDUCTION IN PAIN. THE PAIN MANAGEMENT PHYSICIAN IS NOW DOING STEROID BASED INJECTIONS AS WELL AS MEDICATION MANAGEMENT.