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

Model Number	870160
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
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 causes for the implant blackout are: 1) the ifuse torq tnt implant was placed at the fracture's pivot point - i.E., the part of the bone that is moving the most; 2) the patient fell in postoperative rehabilitation, 3) the patient had urinary tract infection; bacteria could have seeded the ifuse torq tnt implant.
Event or Problem Description
The patient is a woman of approximately 70 years.She had a fall at home with a u-type sacral fracture and right pubic ramus fracture.The surgeon placed one si-bone torq tnt transiliac transsacral screw and one standard transiliac transsacral screw in the s1 corridor.Ifuse torq tnt was placed in/near the transverse fracture line of the sacral u type fracture.Ifuse torq tnt was reported to have good distal ilium purchase, and the case was completed without any problems.Additionally, a non-si-bone screw was placed in the pubic ramus.The patient had back pain after surgery.Mri showed multiple disc problems at l3-l4, l4-l5, and l5-s1.At about two weeks after the initial pelvic surgery, the patient underwent laminectomy/discectomy.The patient fell at an assisted living facility postoperatively.Ct scan showed ifuse torq tnt backout.The patient was medically complicated, with sepsis from uti, as well as wound dehiscence in lumbar spine wound.The patient was noted to be moving around a lot in bed postoperatively.The patient underwent lumbopelvic spine fixation surgery, in which the ifuse torq tnt was removed and pelvic fixation screws were placed.The surgeon did not know the cause of backout.Potential contributors were: 1) the ifuse torq tnt implant was placed at the fracture's pivot point - i.E., the part of the bone that is moving the most; 2) the patient fell in postoperative rehabilitation, 3) the patient had urinary tract infection; bacteria could have seeded the ifuse torq tnt implant.

• Brand Name: IFUSE IMPLANT SYSTEM-TORQ TNT
• 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: carlton reckling ; 471 el camino real; suite 101; santa clara 95050-4482 ; 4082070700
• MDR Report Key: 22205209
• Report Number: 3007700286-2025-00003
• Device Sequence Number: 20554716
• Product Code: OUR
• UDI-Device Identifier: 00810055524402
• UDI-Public: 00810055524402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/12/2025

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 Model Number: 870160
• Device Lot Number: 9104811-004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female