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

Model Number	7080M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	09/11/2020
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 is user error: using an implant that was too long.
Event or Problem Description
The patient had bilateral si joint arthrodesis in september where one implant was in installed on each side in conjunction with a long deformity fusion.The patient reported left side radicular pain following the initial procedure.The surgeon decided to remove the left side implant while he was revising a set screw in case the implant was impinging on the neuroforamen causing radicular pain.Three days after the initial procedure, the surgeon performed a revision procedure where he removed the left side implant and replaced it with a shorter implant of the same type.He also added an additional implant of the same type to the right side.The initial right side implant was not adjusted or removed.The patient's pain symptoms resolved following the revision procedure.

• 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: 10653409
• Report Number: 3007700286-2020-00085
• Device Sequence Number: 16935946
• Product Code: OUR
• UDI-Device Identifier: 00851085007558
• UDI-Public: 00851085007558
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 10/05/2020

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: 01/16/2024
• Device Model Number: 7080M-90
• Device Lot Number: 2656281
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• 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: 84 YR