MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; SACROILIAC JOINT FIXATION

Model Number SEE SECTION H.10

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Reference: voluntary mdr mw5107635: a surgeon reported gluteal artery bleeding occurred upon the installation of the third and final implant during an si joint arthrodesis procedure performed in (b)(6) 2021.The patient has a dysmorphic sacrum.Per the manufacturer: the surgeon reported brisk bleeding and a drop in hemoglobin with use of ifuse implant system during a routine si joint fusion.He suggests that bleeding was due to superior gluteal artery damage resulting from damage related to either instruments or the implant itself.This risk is well known.The rate of severe bleeding with sijf using the ifuse implant system is very low (<0.04%).There have been no changes in rate over the past few years.No action is required.

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 is the surgical procedure.Bleeding is a known, inherit risk or surgery.The patient's abnormal physiology may also have contributed to the adverse event.Part number, lot number, manufacturing date, expiration date and udi/gtin number if applicable 3rd (inferior): ifuse-3d implant, p/n 7040m-90, lot# 2757633, mfd.09/23/20, exp.2025-09-23, gtin (b)(4).Or 3rd (inferior): ifuse-3d implant, p/n 7045m-90, lot# 9037751, mfd.03/01/21, exp.2026-03-01, gtin (b)(4).

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: SACROILIAC JOINT FIXATION
• 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. reckling, m.d. ; 471 el camino real; suite 101; santa clara, CA 95050-4482 ; 4082070700
• MDR Report Key: 14459717
• MDR Text Key: 294779849
• Report Number: 3007700286-2022-00003
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 03/18/2022
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female