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

Model Number	7060M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/30/2021
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 device was out of specification.The most probable root cause for the patient's pain symptoms could not be determined.It is unlikely to be related to the si joint implants.
Event or Problem Description
In (b)(6) 2021, the patient had left side si joint arthrodesis where three implants were installed.The patient reported left thigh pain following the initial procedure.Imaging and neuromonitoring did not show that any of the implants were malpositioned or impinging on the neuroforamen, but the surgeon decided to remove the superior positioned implant to rule it out as the cause of the pain.Approximately two weeks after the initial procedure, the surgeon performed a revision procedure where he removed the superior positioned implant.The explant void was not filled with bone graft and no additional hardware was added.No other preexisting implants were adjusted or removed.The patient's pain symptoms did not resolve following the revision procedure.The surgeon will recommend that the patient's spinal cord stimulator settings be adjusted.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• MDR Report Key: 11701733
• Report Number: 3007700286-2021-00034
• Device Sequence Number: 14367279
• Product Code: OUR
• UDI-Device Identifier: 00851085007381
• UDI-Public: 00851085007381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 10/02/2024
• Device Model Number: 7060M-90
• Device Lot Number: 2694321
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/21/2021
• 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: Other
• Patient Age: 52 YR