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

Model Number	7055-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	09/24/2020
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, 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 initial implant size selection, using too long of an implant or not installing the implant deep enough.
Event or Problem Description
The patient had a right side si joint arthrodesis in (b)(6) 2019 where three implants were installed.The patient later reported to a new surgeon with complaints of pain around the surgical site.The surgeon determined that the cranial positioned implant was too proud of the ilium causing pain around the surrounding tissues.In (b)(6) 2020, the surgeon removed the cranial positioned implant using chisels.No other preexisting implants were adjusted or removed.The patients pain symptoms resolved following the 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: 10708658
• Report Number: 3007700286-2020-00090
• Device Sequence Number: 19650082
• Product Code: OUR
• UDI-Device Identifier: 00851085007503
• UDI-Public: 00851085007503
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 06/15/2025
• Device Model Number: 7055-100
• Device Lot Number: 9009381
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• 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: 57 YR