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	07/30/2020
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: malpositioning of the initial implant.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient later reported unsatisfactory pain relief.The surgeon determined that the inferior positioned implant was positioned too anteriorly and was close to the neuroforamen.In (b)(6) 2020, the surgeon performed a revision procedure where she removed the inferior positioned implant using chisels as it was solidly fixed in bone.No other preexisting implants were adjusted or removed.The status of the patient following the revision procedure is not known.

• 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: 10392312
• Report Number: 3007700286-2020-00066
• Device Sequence Number: 2185987
• 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): 08/06/2020

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: 10/02/2024
• Device Model Number: 7035M-90
• Device Lot Number: 2694271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: 62 YR