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); Pain (1994); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	01/05/2017
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 fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is a malpositioned implant breaching the neuroforamen.
Event or Problem Description
The patient initially had si joint pain relief following si joint arthrodesis in (b)(6) 2016.Two weeks post-op, the patient presented with radicular leg pain complaints.The surgeon determined that the most cephalad implant had breached the neuroforamen and was irritating the nerve root.In (b)(6) 2017, the surgeon performed a revision surgery where he removed the cephalad implant and replaced it with a shorter and wider implant.No other implants were adjusted or removed.The patient's radicular pain symptoms resolved 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: 6256182
• Report Number: 3007700286-2017-00001
• Device Sequence Number: 891237
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 01/17/2017
• 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
• Patient Age: 28 YR