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

Model Number	7040M-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had left si joint arthrodesis in (b)(6) 2021 where three implants were installed.The patient complained of pain following the initial procedure.The surgeon determined that the middle and inferior positioned implants were not positioned fully across the si joint.Two weeks after the initial procedure, the surgeon performed a revision where he removed the inferior positioned implants and replaced it with a shorter implant of the same type.He also impacted the second implant further across joint.The preexisting superior positioned implant was not adjusted or removed.The patient's pain symptoms were reduced following the revision procedure.
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 devices were out of specification.The most probable root cause is user error: not installing the implants fully across the si joint.Additionally, per the surgical technique manual, the surgeon is instructed as follows: "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition.".
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 devices were out of specification.The most probable root cause is user error: not installing the implants fully across the si joint.Additionally, per the surgical technique manual, the surgeon is instructed as follows: "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition.".
Event or Problem Description
The patient had left si joint arthrodesis in (b)(6) 2021 where three implants were installed.The patient complained of pain following the initial procedure.The surgeon determined that the middle and inferior positioned implants were not positioned fully across the si joint.Two weeks after the initial procedure, the surgeon performed a revision where he removed the inferior positioned implants and replaced it with a shorter implant of the same type.He also impacted the second implant further across joint.The preexisting superior positioned implant was not adjusted or removed.The patient's pain symptoms were reduced following the revision procedure.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: 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. reckling, m.d. ; 471 el camino real; suite 101; santa clara, CA 95050-4482 ; 4082070700
• MDR Report Key: 13064285
• Report Number: 3007700286-2021-00134
• Device Sequence Number: 4256545
• Product Code: OUR
• UDI-Device Identifier: 00851085007343
• UDI-Public: 00851085007343
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: 12/31/2025
• Device Model Number: 7040M-90
• Device Lot Number: 9033341
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2025
• 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: 62 YR
• Patient Sex: Female