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

Model Number	7070-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Numbness (2415)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of conformance and fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is malpositioning due to poor preoperative imaging possibly related to the patient's obesity and abnormal pelvic anatomy.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2017 where three implants were placed.The patient is obese and has a dysmorphic sacrum which made preoperative imaging challenging.The patient's si joint pain decreased after the initial procedure, but the patient complained of new right foot pain that became worse over the next few days.The surgeon determined that the most superior implant was impinging on the neuroforamen.Two weeks after the initial procedure, the surgeon performed a revision procedure where he removed the superior positioned implant.No other implants were adjusted or removed.The patient's radicular foot pain improved following the revision 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: 6818199
• Report Number: 3007700286-2017-00083
• Device Sequence Number: 13485852
• Product Code: OUR
• UDI-Device Identifier: 00859256003347
• UDI-Public: 00859256003347
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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: 09/30/2020
• Device Model Number: 7070-90
• Device Lot Number: 493569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/24/2017
• 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