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

Model Number	7065M
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	12/16/2020
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 is implant late loosening.
Event or Problem Description
The patient had bilateral si joint arthrodesis in (b)(6) 2020 where one implant was installed on each side in conjunction with a long spinal fusion construct.The patient later complained or a recurrence of pain symptoms.The surgeon determined lucency around the distal tip of the left side si joint implant and that it may not have been fully fused in bone.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the left side si joint implant using chisels.The explant void was filled with bone graft.The preexisting right side si joint implant was not adjusted or removed.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: 11164920
• Report Number: 3007700286-2020-00131
• Device Sequence Number: 11666721
• Product Code: OUR
• UDI-Device Identifier: 00851085007442
• UDI-Public: 00851085007442
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/11/2021

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: 07/12/2024
• Device Model Number: 7065M
• Device Lot Number: 2691851
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/13/2021
• 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: 56 YR