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

Model Number	SEE SECTION H.10
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	08/19/2020
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: user error: improper initial implant size selection, 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) 2019 where three implants were installed.The patient later reported left side radicular pain.The surgeon determined that the middle positioned implant was malpositioned and impinging on the neuroforamen.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the middle positioned implant.There was significant bone growth on the removed implant.No other preexisting implants were adjusted or removed no other hardware or bone graft was added.The status of the patient following the revision procedure is not known.
Additional Manufacturer Narrative
The most probable root cause could not be determined.The preexisting si joint implants were not loose and were positioned correctly.It was the surgeon's decision to remove the implants and replace them with iliosacral screws in conjunction with a concurrent t10 pelvis revision.The status of the patient following the revision procedure is not known.Part number, lot number, manufacture date, expiration date and gtin.Ifuse-3d implant, p/n: 7040m-90, lot#: 2694281, mfd.10/02/2019, exp.2024-10-02, gtin 00851085007343.Ifuse-3d implant, p/n: 7035m-90, lot#: 9009291, mfd.06/14/2019, exp.2024-06-14, gtin 00851085007305.

• 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: 9901546
• Report Number: 3007700286-2020-00034
• Device Sequence Number: 19536628
• Product Code: OUR
• UDI-Device Identifier: 00851085007343
• UDI-Public: 00851085007343
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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: Other; Required Intervention
• Patient Age: 78 YR