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

Model Number SEE SECTION H.10

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

Patient Problem Bone Fracture(s) (1870)

Event Date 09/08/2021

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.Initial ifuse procedure on 04/26/2021 (bilateral): left: ifuse-3d implant, p/n 7060m-90, lot# 2765071, mfd.(b)(6)2020, exp.2025-01-12, gtin (b)(6).Right: ifuse-3d implant, p/n 7060m-90, lot# 2760611, mfd.(b)(6)2020, exp.2025-10-20, gtin (b)(6).

Event Description

In (b)(6) 2023, si-bone reviewed clinical study adverse events and made the decision to report this adverse event although it is unknown if the implants were the cause of the adverse event.The patient had spine fusion along with the installation of ifuse implants in (b)(6) 2021.Approximately 45 days post-op, the patient presented with sacral fractures.The patient underwent two revisions in (b)(6) 2021 and (b)(6) 2022 where sacral screws were replaced.The ifuse implants were not adjusted or removed.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: 17666985
• MDR Text Key: 322473517
• Report Number: 3007700286-2023-00002
• Device Sequence Number: 1
• Product Code: OUR
• 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: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Male