MAUDE Adverse Event Report: SI-BONE, INC. IFUSE TORQ IMPLANT SYSTEM; SACROILIAC JOINT FIXATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a middle-aged male with a history of polycystic kidney disease.The patient had significant bleeding/bruising after placement of an implantable pump a couple of years ago.The pump was placed to provide patient managed peritoneal dialysis secondary to progressive kidney disease.The physician performed a left si joint fusion on (b)(6) 2024 with implantation of three implants.There was a small amount of bleeding intra-operatively that was easily controlled with local pressure and floseal.There was no bruising or unusual pain immediately post procedure and the patient was discharged home.The patient presented back to the physician's office for the first post op visit with some increased post procedural pain and mild bruising.The physician appreciated only mild local discoloration and no hematoma.The patient was hemodynamically stable and a ct scan at that time demonstrated no acute findings.The patient returned to their home out of state.On or around on (b)(6) 2024, about one month after the procedure, the patient presented to their local out of state er with complaints of increased pain and bruising.A ct angiogram was performed and a pseudoaneurysm of a small branch of the superior gluteal artery was identified.There was no active bleeding.A coil was placed at the conclusion of the procedure.The patient has had no subsequent pain complaints and no additional bruising.The patient likely experienced an injury to a small vessel of the lateral pelvis vascular tree during the si joint fusion procedure.This likely resulted in a pseudoaneurysm.The pseudoaneurysm was diagnosed with a ct angiogram and was treated with placement of a vascular coil.The patient had no permanent injury and has no ongoing issues with bleeding or pain.This event is likely procedure related.This event is low frequency and low severity.
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 injury to a small vessel of the lateral pelvis vascular tree during the si joint fusion procedure.This likely resulted in a pseudoaneurysm.The pseudoaneurysm was diagnosed with a ct angiogram and was treated with placement of a vascular coil.

• Brand Name: IFUSE TORQ IMPLANT SYSTEM
• Common Device Name: SACROILIAC JOINT FIXATION
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer (Section G): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer Contact: carlton reckling ; 471 el camino real; suite 101; santa clara 95050-4482 ; 4082070700
• MDR Report Key: 20467621
• Report Number: 3007700286-2024-00004
• Device Sequence Number: 7242590
• Product Code: OUR
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Male