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

Model Number	7060M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Undesired Nerve Stimulation (1980)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmeas, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is user error; improper implant size selection, using an implant that was too long or placing the implant too deep, likely combined with the patient's dysmorphic and sclerotic sacrum which required an atypical implant installation procedure.
Event or Problem Description
The patient had left side si joint arthrodesis in (b)(6) 2018 where three implants were installed.The patient complained of radicular pain following the procedure.The surgeon determined via ct scan that while the most superior positioned implant had not breached the neuroforamen, a bone fragment was inside the neuroforamen impinging on the nerve root.In (b)(6) 2018, the surgeon performed a minimally invasive hemi-foraminotomy to remove the bone fragment which was successful; however, the patient still had radiculopathy symptoms post-op.The surgeon decided to remove the superior positioned implant.In (b)(6) 2019, the surgeon performed a revision procedure where the superior positioned implant was removed and replaced it with a shorter and wider implant of the same type.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the revision 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 95050 4482
• MDR Report Key: 8379887
• Report Number: 3007700286-2019-00013
• Device Sequence Number: 16250661
• Product Code: OUR
• UDI-Device Identifier: 00851085007381
• UDI-Public: 00851085007381
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 12/12/2022
• Device Model Number: 7060M-90
• Device Lot Number: 2619771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/28/2019
• 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: Required Intervention
• Patient Age: 39 YR