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

Model Number	7045-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pseudoaneurysm (2605)
Date of Event	09/23/2016
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 fmea there is no evidence that the device was out of specification.The most probable root cause is surgical technique and known inherent risk of the surgical procedure.
Event or Problem Description
In (b)(6) 2013, the patient had a left side si joint arthrodesis where two implants were placed.In (b)(6) 2016 the patient had an additional implant added to her left si joint.In (b)(6) 2016, it was learned that the patient developed a gluteal hematoma and gluteal artery pseudoaneurysm in (b)(6) 2016, after the additional implant procedure.The pseudoaneurysm was coiled and the hematoma was irrigated and debrided.No implants were removed.The patient suffered no permanent sequelae and was better after the procedure.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 2066
• MDR Report Key: 6149363
• Report Number: 3007700286-2016-00094
• Device Sequence Number: 893419
• Product Code: OUR
• UDI-Device Identifier: 00859256003293
• UDI-Public: 00859256003293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

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: 03/16/2021
• Device Model Number: 7045-90
• Device Lot Number: 493622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 12/06/2016
• 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; Required Intervention
• Patient Age: 68 YR