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

Model Number	7070M-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
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 is user error; improper implant size selection, using too long of an implant or implanting the implant too deep.
Event or Problem Description
The patient had a right side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient reported right side radicular pain following the initial procedure.The surgeon determined that the cranial positioned implant had breached the neuroforamen causing radicular pain.In (b)(6) 2020, the surgeon attempted to remove the cranial implant, but he was unable to remove the implant using chisels as it was solidly fixed in bone.The surgeon is considering performing an s1 nerve root decompression at a later date.No other preexisting implants were adjusted or removed.The patients radicular pain symptoms have not resolved.
Additional Manufacturer Narrative
Updated: in (b)(6) 2020, a different surgeon was able to successfully remove the cranial implant using the chisels.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.
Event or Problem Description
The patient had a right side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient reported right side radicular pain following the initial procedure.The surgeon determined that the cranial positioned implant had breached the neuroforamen causing radicular pain.In (b)(6) 2020, the surgeon attempted to remove the cranial implant, but he was unable to remove the implant using chisels as it was solidly fixed in bone.The surgeon is considering performing an s1 nerve root decompression at a later date.No other preexisting implants were adjusted or removed.The patients radicular pain symptoms have not resolved.Updated: in (b)(6) 2020, a different surgeon was able to successfully remove the cranial implant using the chisels.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.

• 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: 10840735
• Report Number: 3007700286-2020-00103
• Device Sequence Number: 4089477
• Product Code: OUR
• UDI-Device Identifier: 00851085007459
• UDI-Public: 00851085007459
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 06/12/2023
• Device Model Number: 7070M-100
• Device Lot Number: 2641591
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: 32 YR