MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD

Model Number	7045M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique guide, ifu, certificates of analysis and fmeas, there is no evidence that the device was out of specification.The event was procedural.The most probable root cause is the surgical procedure.
Event or Problem Description
The surgeon was performing a right side si joint arthrodesis in (b)(6) 2020 when he noticed significant bleeding from the wound site.Bleeding was found by ir to be coming from the superior gluteal artery.The patient has a previously installed spinal cord stimulator in the right gluteal region.The surgeon used the aquamantys (hemostatic sealing device) to locate and cauterize the bleed.Blood loss was estimated to be around 1.5 l.The patient received 2 units of rbcs in transfusion.The patient remained hemodynamically stable.The surgical incision was closed, and the patient was transferred to the hospital.The implant was left in place.No additional implants were placed.This is a case of vascular injury (a branch of the superior gluteal artery).It is unusual for a surgeon to experience this type of injury with placement of the most cephalad implant.The branches of the superior gluteal artery become smaller as they arborize in a cephalad direction in the gluteal musculature.This is a low frequency occurrence.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• MDR Report Key: 9673284
• Report Number: 3007700286-2020-00005
• Device Sequence Number: 11491352
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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 Expiration Date: 09/09/2024
• Device Model Number: 7045M-90
• Device Lot Number: 2692111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 73 YR