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

Model Number	SEE SECTION H.10
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	06/30/2020
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: using too long of an implant or installing the implant too deep.
Event or Problem Description
The patient had left side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient's si joint pain resolved but he complained of left leg pain four days later.The surgeon determined that the inferior positioned implant was impinging on the neuroforamen.One week after the initial procedure, the surgeon performed a revision procedure where she removed the implant.No bone graft or additional hardware was added.No other preexisting implants were adjusted or removed.The patient's pain symptoms resolved following the revision procedure.
Additional Manufacturer Narrative
Previous revision to remove one of three si joint implants due to possible nerve impingement occurred in (b)(6) 2020.The patient complained of continued leg pain after the first revision.In (b)(6) 2020, the surgeon removed the remaining two si joint implants.The patient's pain symptoms resolved following the second revision procedure.Part numbers, lot numbers, manufacturing dates, expiration dates and udi/gtin numbers: 1st (superior): ifuse-3d implant, p/n 7055m-90, lot# 2717691, mfd.12/17/19, exp.2024-12-17, gtin (b)(4); 2nd (middle): ifuse-3d implant, p/n 7050m-90, lot# 2694381, mfd.10/30/19, exp.2024-10-30, gtin (b)(4).
Event or Problem Description
See section h.10.

• 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: 10160519
• Report Number: 3007700286-2020-00049
• Device Sequence Number: 16821045
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• 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,Followup
• Report Date (Section B): 07/20/2020

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: 01/28/2025
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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: 70 YR