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

Model Number	7050-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355)
Date of Event	10/05/2017
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 could not be determined.
Event or Problem Description
The patient had initial right side si joint arthrodesis in (b)(6) 2016.The patient complained of leg pain sometime after the initial surgery.In (b)(6) 2016, the surgeon performed a revision surgery where he removed the first and third implants that he suspected were impinging on the nerve root, leaving the middle implant in place (previously reported on mdr 3007700286-2016-00046).The patient later had a recurrence of pain.The surgeon thought that the sole remaining implant may have been loose.In (b)(6) 2016, the surgeon attempted to remove the remaining implant, but it was solidly fixed in bone and could not be removed.It was not loose.The surgeon left the implant in place and debrided the joint and added bone graft.The status of the patient following the surgery is not yet known.
Additional Manufacturer Narrative
The patient underwent an additional revision procedure in an attempt to stabilize the pelvis.One implant from each side removed and additional hardware was added including an ifuse implant.Challenging case with three previous attempts to fuse the si joint following a car accident and decades of pain.The patient is improving following the 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: 6182988
• Report Number: 3007700286-2016-00098
• Device Sequence Number: 185204
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: 12/18/2019
• Device Model Number: 7050-90
• Device Lot Number: 223222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 10/24/2017
• 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
• Patient Age: 44 YR