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

Model Number	7050M-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Undesired Nerve Stimulation (1980)
Date of Event	06/17/2021
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 for is user error: 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
The patient had a previous lumbar fusion.In (b)(6) 2021, the surgeon performed a left side si joint arthrodesis on the patient where three implants were installed.The patient had si joint pain relief, but later reported new radicular pain.It was determined that the superior positioned implant was malpositioned too cephalad and not fully contained with the osseous envelope of the sacral ala resulting in fractures of the sacral alar cortical wall.The tip of the implant was outside of the sacrum and in the proximity of the l5 nerve root causing radicular pain.In (b)(6) 2021, the surgeon performed a revision procedure where he removed the superior positioned implant using chisels.He then installed a shorter implant of the same type in an inferior position below the existing implants.No other preexisting implants were adjusted or removed.The patient's l5 pain symptoms improved 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: 12178182
• Report Number: 3007700286-2021-00072
• Device Sequence Number: 936701
• 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: 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): 07/13/2021

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: 12/01/2025
• Device Model Number: 7050M-100
• Device Lot Number: 2765061
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: 48 YR