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

Model Number	7035-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2018
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 devices were out of specification.The most probable root cause is improper implant size selection or not installing the implant deep enough.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2016 where three implants were placed.The patient had an eight-month period of pain relief before later reporting to a new surgeon with a recurrence of pain complaints.The surgeon determined that the most caudal positioned implant was too proud of the ilium causing pain around the proximal end of the implant.In (b)(6) 2018, the surgeon performed a revision procedure where he removed the caudal implant.No other preexisting implants were adjusted or removed.The status of the patient following the revision procedure is not known.

• 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: 7306735
• Report Number: 3007700286-2018-00017
• Device Sequence Number: 13762453
• Product Code: OUR
• UDI-Device Identifier: 00859256003279
• UDI-Public: 00859256003279
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 03/11/2020
• Device Model Number: 7035-90
• Device Lot Number: 333349
• 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: 02/21/2018
• Initial Report FDA Received Date: 03/01/2018
• 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: Required Intervention
• Patient Age: 77 YR