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

Model Number	7050M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	05/10/2021
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; improper implant size selection, using too long of an implant or installing 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 was impinging on the neuroforamen causing radicular pain.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the cranial positioned implant.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the revision procedure.
Additional Manufacturer Narrative
Previous revision: in (b)(6) 2020, the surgeon performed a revision procedure where he removed the cranial positioned implant.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the revision procedure.Updated: patient reported to the same a new surgeon with a recurrence of radicular pain symptoms.The surgeon removed the middle implant with chisels as it was solidly fixed in bone.He then installed a new, shorter, implant of the same type into the explant void.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the additional revision procedure.Based on the information provided, review of the surgical technique manual, certificates of analysis, ifu 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: using too long of an implant.Additionally, per the surgical technique manual, the surgeon is instructed as follows: "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition.".
Event or Problem Description
Previous revision: in (b)(6) 2020, the surgeon performed a revision procedure where he removed the cranial positioned implant.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the revision procedure.Updated: patient reported to the same a new surgeon with a recurrence of radicular pain symptoms.The surgeon removed the middle implant with chisels as it was solidly fixed in bone.He then installed a new, shorter, implant of the same type into the explant void.No other preexisting implants were adjusted or removed.The patient's radicular pain symptoms resolved following the additional 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 95050 4482
• MDR Report Key: 10856227
• Report Number: 3007700286-2020-00105
• Device Sequence Number: 641833
• Product Code: OUR
• UDI-Device Identifier: 00851085007510
• UDI-Public: 00851085007510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 06/01/2021

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: 7050M-90
• Device Lot Number: 2717681
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 06/02/2021
• 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: 50 YR