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

Model Number	7070M-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Undesired Nerve Stimulation (1980)
Date of Event	10/02/2021
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 may be user error: malpositioning of the 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 previous lumbar fusion.In (b)(6) 2021, the surgeon performed a right side si joint arthrodesis on the patient installing one implant while revising a lumbar construct.The patient reported radicular pain two weeks after the procedure.The surgeon determined that there was a small, comminuted fracture just superior to the sciatic notch area at the top of the implant.In (b)(6) 2021, the surgeon performed a revision procedure where he removed the implant and installed an iliac bolt superior to the explant void.No bone graft was placed in the explant void and no other preexisting implants were adjusted or removed.The patients 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: 12716307
• Report Number: 3007700286-2021-00103
• Device Sequence Number: 4920757
• Product Code: OUR
• UDI-Device Identifier: 00851085007541
• UDI-Public: 00851085007541
• 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): 10/26/2021

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: 02/09/2026
• Device Model Number: 7070M-100
• Device Lot Number: 9034881
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2021
• Initial Report FDA Received Date: 10/28/2021
• 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: 63 YR