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	08/20/2019
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 left side si joint arthrodesis on the patient in (b)(6) 2019 when he encountered venous bleeding after the placement of the first implant.The surgeon used pressure, thrombotic material and hemostatic sealing to control the bleeding.The surgeon aborted the procedure after adding only one of three implants.The patient was admitted to the hospital for observation.The patient remained hemodynamically stable.The patient had no new neurologic findings of numbness or weakness, specifically no weakness of the gluteus musculature.The patient did not require a transfusion.The patient was discharged to home the first post-operative day.This is a low frequency, low severity case.The patient suffered no permanent injury.In (b)(6) 2019, the surgeon performed an additional procedure to add three additional implants of the same type to the left si joint.No unusual bleeding occurred during the procedure.

• 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
• MDR Report Key: 9753535
• Report Number: 3007700286-2020-00020
• Device Sequence Number: 16810271
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 06/13/2024
• Device Model Number: 7045M-90
• Device Lot Number: 9009311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: 58 YR