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

Model Number	SEE SECTION H.10
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Arthralgia (2355)
Date of Event	03/28/2018
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 improper implant size selection.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2018 where three implants were placed.The patient complained of radicular pain following the procedure.The surgeon determined that the cranial positioned implant had breached the neuroforamen.Five days after the initial procedure, the surgeon performed a revision procedure where he removed the implant.The patient's radicular pain symptoms resolved following the revision procedure.
Additional Manufacturer Narrative
The patient complained of continued non-radicular pain after one right side si joint implant was removed in (b)(6) 2018 and requested that the remaining right side si joint implants be removed.In (b)(6) 2018, the surgeon removed the remaining two implants.The status of the patient following the removal revision is not known.Part numbers, lot numbers, manufacturing dates, expiration dates and udi/gtin numbers: 2nd (middle): ifuse implant, p/n 7045-90, lot# 493982, mfd.08/10/17, exp.2022-08-10, udi (b)(4).3rd (inferior): ifuse implant, p/n 7040-90, lot# 493928, mfd.05/25/17, exp.2022-05-25, udi (b)(4).

• 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: 7222807
• Report Number: 3007700286-2018-00008
• Device Sequence Number: 2248210
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 07/28/2022
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 04/11/2018
• 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: Other; Required Intervention
• Patient Age: 46 YR