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

Model Number	7055M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
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 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
• Common Device Name: 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
• Report Number: 3007700286-2022-00004
• Device Sequence Number: 5485983
• Product Code: OUR
• UDI-Device Identifier: 00851085007350
• UDI-Public: 00851085007350
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 05/13/2026
• Device Model Number: 7055M-90
• Device Lot Number: 9044251
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male