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

Model Number	7045M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, and fmea, the most probable root cause is user error; improper implant size selection, using too long of an implant.Additionally, per the surgical technique manual, the surgeon is instructed as follows: "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition.".
Event or Problem Description
The patient had a left side si joint arthrodesis in (b)(6) 2020 where two implants were installed.The patient initially had si joint pain relief but reported left side radicular pain shortly after the initial procedure.The surgeon determined that the caudal positioned implant was too long and was impinging on the neuroforamen causing radicular pain.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the caudal positioned implant and replaced it with a shorter implant of the same type using the explant void.He then added an additional implant of the same type to the left si joint.The preexisting cranial positioned implant was not adjusted or removed.The patient now has three implants in her left si joint.The patient's radicular 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: 10856107
• Report Number: 3007700286-2020-00111
• Device Sequence Number: 641832
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• 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): 11/17/2020

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: 03/03/2025
• Device Model Number: 7045M-90
• Device Lot Number: 2728311
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/17/2020
• 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: 67 YR