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	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, and fmeas, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is malpositioned implant due to altered pelvic anatomy from a previous trauma incident.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 automobile trauma pelvic injury treated with pubic symphysis plating and iliosacral screw fixation.The patient had a collapsed structure of the sacral ala because of the original injury.In (b)(6) 2021, the surgeon performed a left side si joint arthrodesis on the patient where three implants were installed.There were no intra-operative complications and no immediate post-operative complications.The patient later reported weakness of the left ankle dorsi and plantar flexion.The surgeon determined displacement of the l5 nerve root so that it was positioned in an adherent location in the vicinity of the superior positioned implant.The altered anatomy of the sacral ala because of the traumatic pelvic ring fracture significantly contributed to the l5 nerve irritation/injury.The altered pelvic anatomy may have made imaging difficult during the implant installation procedure.In (b)(6) 2021, 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 was doing well 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: 11424265
• Report Number: 3007700286-2021-00004
• Device Sequence Number: 19846938
• Product Code: OUR
• UDI-Device Identifier: 00851085007459
• UDI-Public: 00851085007459
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 05/13/2024
• Device Model Number: 7070M-100
• Device Lot Number: 9009351
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/05/2021
• 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: 65 YR