IFUSE TORQ IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE INFECTION IS THE SURGICAL PROCEDURE OR LATER SI JOINT INJECTION. INDEX SURGERY IMPLANTS INSTALLED ON (B)(6) 2024: 1ST (SUPERIOR): IF USE TORQ IMPLANT, P/N 11565T, LOT 9082231, MFD. 04/19/2023, EXP. 2028-04-19, GTIN (B)(4); 2ND (MIDDLE): IF USE TORQ IMPLANT, P/N 11540T, LOT 9090981, MFD. 03/28/2024, EXP. 2029-03-28, GTIN (B)(4); 3RD (INFERIOR): IF USE TORQ IMPLANT, P/N 11540T, LOT 9090971, MFD. 03/28/2024, EXP. 2029-03-28, GTIN (B)(4).

Description of Event or Problem

PER SI-BONE CHIEF MEDICAL OFFICER: THE INDEX CASE WAS A LEFT SIDED SIJ FUSION USING TORQ IN (B)(6) 2024. THE PATIENT IS A 70 YEAR OLD MALE. THE PATIENT HAD RECURRENCE OF PAIN ONE WEEK AFTER THE PROCEDURE. PAIN WAS WORSE WITH AMBULATION, BETTER WITH LYING DOWN. THE FIRST IMPLANT WAS PROUD ON FLUORO IMAGING. THE PHYSICIAN SHARED THAT THIS AREA WAS NOT OVERLY TENDER TO PALPATION. POSSIBLE REASONS FOR THE INCREASED PAIN INCLUDING THE POSSIBILITY OF A FRACTURE OF THE ILIUM AND ALSO THE POSSIBILITY OF FLUID COLLECTION SUCH AS A HEMATOMA WERE DISCUSSED WITH THE PHYSICIAN AS WELL AS A CT SCAN AS A FIRST LINE AS THIS WOULD SHOW BETTER ANATOMIC DETAIL AROUND THE IMPLANTS. THE PHYSICIAN SHARED NO ADDITIONAL INFORMATION REGARDING PATIENTS OVERALL HEALTH OR ANY SYSTEMIC COMPLAINTS. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL WITH AN ABSCESS IN (B)(6) 2024. THE PHYSICIAN HAD PERFORMED AN INJECTION INTO THE SURGICAL SITE THE WEEK PRIOR FOR ATTEMPTED PAIN CONTROL. THE INJECTION PROCEDURE WAS PERFORMED IN THE PHYSICIAN'S OFFICE. NO DETAILS REGARDING WHAT WAS INJECTED WERE SHARED. THERE WERE SOME CHALLENGES GETTING SURGICAL SUPPORT TO HELP MANAGE THE CASE. INTERVENTIONAL RADIOLOGY ATTEMPTED TO DRAIN THE ABSCESS. A SURGEON SUBSEQUENTLY DEBRIDED THE WOUND AND REMOVED THE IMPLANTS. THE PATIENT DID REQUIRE A SECONDARY HOSPITALIZATION AND AN ADDITIONAL SURGERY. MY MEDICAL OPINION IS THAT THE REPORTED INJECTION INTO THE SURGICAL SITE WAS A SIGNIFICANT CONTRIBUTING FACTOR TO THE INFECTION.