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

Model Number	7040-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Disorder (2373); Osteopenia/ Osteoporosis (2651)
Date of Event	10/07/2016
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 implant loosening possibly due to the patient's osteoporosis.
Event or Problem Description
In (b)(6) 2015, the patient underwent a right side si joint arthrodesis where three implants were placed.The patient initially had pain relief following the procedure but later had a recurrence of si joint pain.The surgeon determined via x-rays and ct scans that there was lucency around the most caudal implant.The patient has osteoporosis.In (b)(6) 2016, the surgeon performed a revision surgery where he removed the most caudal implant and filled the explant hole with bone graft.He then added an additional implant dorsal to the most cephalad preexisting implant.The status of the patient following the revision surgery is not yet 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: 6018979
• Report Number: 3007700286-2016-00078
• Device Sequence Number: 18975305
• Product Code: OUR
• UDI-Device Identifier: 00859256003286
• UDI-Public: 00859256003286
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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: 01/29/2020
• Device Model Number: 7040-90
• Device Lot Number: 322229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 10/11/2016
• 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: 64 YR