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

Model Number	7050-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Arthralgia (2355); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	09/20/2016
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 impinging on the nerve root.
Event or Problem Description
The patient had left side si joint arthrodesis in (b)(6) 2016 where three implants were placed.The patient had an initial period of pain relief but later complained of leg pain.The surgeon determined via ct scans and neuromonitoring that the most proximal implant had breached the ala and was slightly impinging on the nerve root causing the leg pain.In (b)(6) 2016, the surgeon performed a revision surgery where he removed the left side proximal implant using chisels as there was a considerable amount of bone growth on the implant.No other implants were adjusted or removed.The patient is doing better 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: 5973543
• Report Number: 3007700286-2016-00070
• Device Sequence Number: 912447
• Product Code: OUR
• UDI-Device Identifier: 00859256003309
• UDI-Public: 00859256003309
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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: 12/22/2020
• Device Model Number: 7050-90
• Device Lot Number: 493594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 09/23/2016
• 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: 66 YR