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

Model Number	7030-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355)
Date of Event	04/11/2017
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 may be implant loosening.
Event or Problem Description
The patient had staged bilateral si joint arthrodesis with the right side being performed in (b)(6) 2016.The patient had over six months of si joint pain relief before complaining of a recurrence of right side si joint pain.The surgeon thought that the most inferior implant may have been loose.In (b)(6) 2017, the surgeon performed a revision surgery where he removed the inferior implant and replaced it with a larger diameter implant of the same type using the same explant hole.He then added an additional implant in a more anterior position to the existing implants to help fixate the si joint.The patient is doing well following the revision procedure and her pain is "under control.".

• 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: 6527230
• Report Number: 3007700286-2017-00032
• Device Sequence Number: 885427
• Product Code: OUR
• UDI-Device Identifier: 00859256003262
• UDI-Public: 00859256003262
• 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): 04/25/2017

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: 08/26/2019
• Device Model Number: 7030-90
• Device Lot Number: I0A71
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/27/2017
• 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: 62 YR