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

Model Number 7055M-90

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/09/2022

Event Type  Injury  

Event Description

In (b)(6) 2022, the surgeon was performing a left side si joint arthrodesis on the patient when he encountered significant bleeding after broaching/impacting for the second implant.The sga or a branch was possibly damaged.A single implant was placed adequately.When the instruments were removed, the surgeon observed excessive bleeding.Patient underwent coil embolization of branch of the sga by another physician.A week later, two more implants were placed without incident.This is a low occurence event at <.04% of all procedures performed.

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.

• 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: 14962187
• MDR Text Key: 295597581
• Report Number: 3007700286-2022-00004
• Device Sequence Number: 1
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7055M-90
• Device Lot Number: 9044251
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male