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

Model Number	7055M-90
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had bilateral si joint arthrodesis in (b)(6) 2021 where three implants were installed on each side.The patient later complained of continued si joint pain.The patient reported right side leg pains following the initial procedure.The surgeon did not determine that any of the right side implants were malpositioned but decided to remove the right side superior positioned implant regardless.Two weeks after the initial procedure, the surgeon performed a revision procedure where he removed the right side superior positioned implant.The explant void was not filled with bone graft or other hardware.No other preexisting implants were adjusted or removed.The status of the patient following the revision procedure is not known.
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 could not be conclusively determined, but it is possible that an implant may have been malpositioned and was impinging on the nerve causing leg pain.Malpositioning and/or using too long of an implant is use error.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.".

• 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: 12667131
• Report Number: 3007700286-2021-00107
• Device Sequence Number: 4298391
• Product Code: OUR
• UDI-Device Identifier: 00851085007374
• UDI-Public: 00851085007374
• 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): 10/13/2021

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: 04/02/2026
• Device Model Number: 7055M-90
• Device Lot Number: 9039131
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/20/2021
• 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: Other
• Patient Age: 57 YR