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

Model Number	7055-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Arthralgia (2355); Joint Disorder (2373); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	04/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique guide, ifu, certificates of conformance and fmea, the most probable root cause is the patient's anatomy.The implant was irritating a nerve near a lumbosacral transitional vertebrae.
Event or Problem Description
In (b)(6) 2015, the patient had a left side si joint arthrodesis where three implants were placed.The patient had initial pain relief following the procedure but complained of radicular pain a week later.The surgeon determined via ct scan that the implants were in the correct position and not impinging on any neuroforamen.He did discover that the patient had a lumbosacral transitional vertebrae that may have been causing nerve irritation with the most superior positioned implant.In (b)(6) 2016, the surgeon performed a revision surgery on the patient's left si joint where he removed the superior implant.The implant was solidly fixed in the ilium and required considerable effort to remove it.The explant hole was not filled with bone graft.The patient's radicular pain symptoms resolved completely following the revision surgery.

• 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: 5582187
• Report Number: 3007700286-2016-00030
• Device Sequence Number: 19076014
• Product Code: OUR
• UDI-Device Identifier: 00859256003316
• UDI-Public: 00859256003316
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2016

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: 05/31/2020
• Device Model Number: 7055-90
• Device Lot Number: 373339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2016
• Initial Report FDA Received Date: 04/15/2016
• 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: Required Intervention
• Patient Age: 49 YR