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

Model Number 7070M-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, review of the surgical technique guide, 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 fracture could not be determined.Bone fracture is a known risk of placement of metallic devices into pelvic bone.

Event Description

In (b)(6) 2023, si-bone learned of an ilium fracture case that had occurred in late 2021.The patient had multilevel spine fusion surgery with placement of both pelvic fixation screws and ifuse in the sai configuration on (b)(6) 2021.About 2 weeks post-op, the patient heard a pop.Ct scan shows a large, displaced ilium fracture.The surgeon installed screws a few month later to help fixate the ilium fracture.It is unknown whether the ifuse implants were causally related, but it was the implant that was closest to the fracture location and patient movement can impose a large lever force on the pelvic bones.Bone fracture is a known risk of placement of metallic devices into pelvic bone.

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer (Section G): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer Contact: w. carlton reckling ; 471 el camino real; suite 101; santa clara, CA 95050-4482 ; 4082070700
• MDR Report Key: 17666938
• MDR Text Key: 322473197
• Report Number: 3007700286-2023-00001
• Device Sequence Number: 1
• Product Code: OUR
• UDI-Device Identifier: 00851085007541
• UDI-Public: 00851085007541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7070M-100
• Device Lot Number: 9046141
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male