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

Model Number	7035-100
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	09/17/2021
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 were out of specification.The most probable root cause is user error: improper implant size selection, using implants that were too short.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
The patient had left side si joint arthrodesis in (b)(6) 2021 where three implants were installed.The patient later complained of continued slight si joint pain.The surgeon determined that the caudal positioned ifuse implant was too short and not fully across the si joint.In (b)(6) 2021, the surgeon performed a revision procedure where he removed the caudal positioned implant and replaced it with a longer implant of the same type using the explant void.No other preexisting implants were adjusted or removed.The patient's 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: 12677800
• Report Number: 3007700286-2021-00109
• Device Sequence Number: 11802573
• Product Code: OUR
• UDI-Device Identifier: 00859256003279
• UDI-Public: 00859256003279
• 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: 2021
• 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
• Report Date (Section B): 10/19/2021

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: 11/14/2023
• Device Model Number: 7035-100
• Device Lot Number: 494422
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/21/2021
• 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
• Patient Age: 76 YR