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

Model Number	7050M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	04/01/2021
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 is user error: installing too long of an implant and implant malpositioning.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
In (b)(6) 2020, the patient had right side si joint arthrodesis where three implants were installed.The patient had si joint pain relief following the initial surgery but later reported radicular pain symptoms.The surgeon determined that the middle positioned implant was too long and malpositioned and was impinging on the neuroforamen causing radicular pain symptoms.In (b)(6) 2021, the surgeon performed a revision procedure where he first removed the superior positioned implant using chisels solely to access the middle implant.There were no complaints about the superior positioned implant.He then removed the middle positioned implant using chisels as it was solidly fixed in bone and installed a shorter implant of the same type into the explant void.He also installed a new implant of the same type in the superior explant void.The preexisting inferior positioned implant was not adjusted or removed.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: 11749919
• Report Number: 3007700286-2021-00048
• Device Sequence Number: 4175839
• Product Code: OUR
• UDI-Device Identifier: 00851085007367
• UDI-Public: 00851085007367
• 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: 2020
• 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): 04/27/2021

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: 03/05/2025
• Device Model Number: 7050M-90
• Device Lot Number: 2728321
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: Required Intervention
• Patient Age: 56 YR