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

Model Number	7075M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	02/01/2021
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 for the infection is the surgical procedure and the patient's condition.
Event or Problem Description
There was no problem with the si joint implants or the placement of the si joint implants.The patient had bilateral si joint fusion in conjunction with a spinal long construct in (b)(6) 2019.The patient later developed an infection at the surgery site.The patient has a previous history of infections.The surgeon determined that the spinal screws were loose, but that the si joint implants were solid.In (b)(6) 2021, the surgeon decided to remove the spinal hardware and si joint implants.The surgeon did not think that the infection was related to the si joint implants.In (b)(6) 2021, the surgeon removed the left and right side spinal screws and rods.He also removed the right side si joint implant using chisels as it was solidly fixed in bone.The left side si joint implant was solidly fixed in bone and was left in place.The surgeon closed the wound with sutures using antibiotic balls.The patient is doing well following the revision procedure and has been released to go home.

• 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: 11395820
• Report Number: 3007700286-2021-00014
• Device Sequence Number: 13744799
• Product Code: OUR
• UDI-Device Identifier: 00851085007527
• UDI-Public: 00851085007527
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 01/16/2024
• Device Model Number: 7075M-90
• Device Lot Number: 2656271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 70 YR