IFUSE 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 BLEEDING IS THE SURGICAL PROCEDURE AND SUB-OPTIMAL IMPLANT PLACEMENT.

Description of Event or Problem

PER SI-BONE CMO: THE SI JOINT ARTHRODESIS SURGERY WAS BEING PERFORMED AT AN AMBULATORY SURGERY CENTER WITH A VERY EXPERIENCED SURGEON. THE SURGEON EXPERIENCED BLEEDING FROM THE LATERAL SOFT TISSUES DURING PLACEMENT OF THE 3RD (CAUDAL) IMPLANT. THE SURGEON SPENT A SIGNIFICANT AMOUNT OF TIME MANAGING THE BLEEDING. THE SURGEON EXTENDED THE INCISION AND EVENTUALLY WAS ABLE TO IDENTIFY THE INJURED ARTERIAL VESSEL IN THE LATERAL SOFT TISSUES AND CAUTERIZE IT WITH BIPOLAR FORCEPS. THE SURGEON APPRECIATED A SIGNIFICANT AMOUNT OF ADDITIONAL BLEEDING COMING FROM AROUND THE CAUDAL IMPLANT. THE SURGEON SHARED THAT THE IMPLANT WAS MORE VENTRAL THAN IDEAL. HE REMOVED THE IMPLANT TO BETTER ASSESS THE SOURCE OF THE BLEEDING. HE PACKED WITH GELFOAM AND FLOWSEAL AND THE BLEEDING DID NOT STOP. THE PATIENT WAS STABLE. THE BLEEDING MAY HAVE BEEN COMING FROM THE PERIOSTEUM AND THE SOFT TISSUE OF VENTRAL SACRUM AS THE IMPLANT MAY HAVE CROSSED INTO THIS AREA. THE SURGEON PACKED THE BONE VOID AND CLOSED THE WOUND. THE PATIENT WAS TRANSFERRED TO THE LOCAL HOSPITAL. AT THE HOSPITAL, THE PATIENT HAD A CT ANGIOGRAM. THE CT ANGIOGRAM SHOWED NO ACTIVE BLEEDING IN THE PELVIS OR IN THE LATERAL SOFT TISSUES. THERE WAS NO SIGNIFICANT HEMATOMA. THE PATIENT REMAINED STABLE THROUGHOUT THE POST OPERATIVE COURSE FROM RECOVERY AT THE ASC, THROUGH TRANSFER TO THE HOSPITAL AND THROUGH AND AFTER THE CTA PROCEDURE. MEDICAL ASSESSMENT: THERE WAS BLEEDING COMING FROM TWO SOURCES IN THIS CASE. THE FIRST SOURCE OF BLEEDING WAS FROM AN INJURY TO ONE OF THE ARTERIAL BRANCHES OF THE SGA IN THE LATERAL SOFT TISSUES OF THE PELVIS. THE BLEEDING FROM THIS VESSEL WAS CONTROLLED. THE PATIENT ALSO HAD BLEEDING COMING FROM THE BONE AND POTENTIALLY THE VENTRAL SOFT TISSUES IN THE AREA OF THE 3RD IMPLANT. THE 3RD IMPLANT WAS DESCRIBED AS BEING VENTRAL. IT IS POSSIBLE THAT THE IMPLANT VIOLATED THE OSSEOUS ENVELOPE OF THE SACRUM WITH DISRUPTION OF THE PERIOSTEUM AND THE SOFT TISSUE ALONG THE VENTRAL ASPECT OF THE SACRUM. THE BLEEDING MAY ALSO HAVE BEEN COMING FROM THE BONE ITSELF. CT ANGIOGRAM SHOWED NO ONGOING BLEEDING. THIS PATIENT DID REQUIRE ADDITIONAL MEDICAL CARE THAT WAS NOT PLANNED (TRANSFER TO HOSPITAL, CT ANGIOGRAM, OVERNIGHT STAY IN THE HOSPITAL). THE PATIENT, PER REPORT, DID NOT SUFFER ANY CARDIOVASCULAR EVENT AND SUFFERED NO PERMANENT INJURY. FOLLOW-UP (B)(6) 2025: THE PATIENT IS DOING WELL.