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

Model Number	7080M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	05/04/2021
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 cause could not be determined.It was the surgeon's decision to remove the implant at the patient's request.
Event or Problem Description
The patient had trauma from a motor vehicle accident.In (b)(6) 2020, the patient had left side si joint arthrodesis during a trauma procedure where one implant was installed across the si joint.The patient later complained about low back pain.The surgeon did not indicate that the implant was malpositioned or loose.There was no nerve impingement.The surgeon decided that the best course of action was to remove the implant at the patient's request.In (b)(6) 2021, the surgeon performed a revision procedure where he removed the implant using chisels as the implant was solidly fixed in bone.No bone graft or new hardware was added to the si joint.The status of the patient following the revision procedure is not known.

• 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
• MDR Report Key: 11925897
• Report Number: 3007700286-2021-00055
• Device Sequence Number: 3831477
• Product Code: OUR
• UDI-Device Identifier: 00851085007558
• UDI-Public: 00851085007558
• 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: 2020
• 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): 06/02/2021

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: 12/18/2024
• Device Model Number: 7080M-90
• Device Lot Number: 2720531
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR