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

Model Number	7035M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmea, the most probable root cause is user error: installing the implant too deep.Part number, lot number, manufacturing date, expiration date and gtin: 1st (superior): ifuse-3d implant, p/n 7040m-90, lot# 2694441, mfd.11/19/19, exp.2024-11-19, gtin (b)(4).2nd (middle): ifuse-3d implant, p/n 7045m-90, lot# 2717671, mfd.12/17/19, exp.2024-12-17, gtin (b)(4).3rd (inferior): ifuse-3d implant, p/n 7035m-90, lot# 2717651, mfd.12/17/19, exp.2024-12-17, gtin (b)(4).
Event or Problem Description
The patient had left side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient had si joint pain relief but later reported left side radicular pain symptoms.The surgeon determined that the inferior positioned implant had pushed bone fragments into the si nerve root causing radicular pain.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the inferior positioned implant and installed a new implant of the same type adjacent to the explant void.No other preexisting implants were 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
• MDR Report Key: 10336342
• Report Number: 3007700286-2020-00060
• Device Sequence Number: 17008982
• Product Code: OUR
• UDI-Device Identifier: 00851085007305
• UDI-Public: 00851085007305
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 12/17/2024
• Device Model Number: 7035M-90
• Device Lot Number: 2717651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/28/2020
• 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: 57 YR