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

Model Number	7045M-100
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Arthralgia (2355)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, certificates of analysis, ifu and fmeas, the most probable root cause is implant loosening possibly due to a microfracture.
Event or Problem Description
The patient had si joint arthrodesis around (b)(6) 2019 where three implants were installed.The patient reported si joint pain symptoms following the procedure.The surgeon later determined that the caudal positioned implant may have been loose due to a microfracture in the bone around the implant.In (b)(6) 2020, the surgeon performed a revision surgery where he removed the caudal positioned implant using chisel and filled the explant void with bone graft.No other medical procedure was performed to treat the microfracture.No other preexisting implants were adjusted or removed.The patient's pain symptoms resolved 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
• MDR Report Key: 10360251
• Report Number: 3007700286-2020-00059
• Device Sequence Number: 14010323
• Product Code: OUR
• UDI-Device Identifier: 00851085007497
• UDI-Public: 00851085007497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 06/18/2023
• Device Model Number: 7045M-100
• Device Lot Number: 2641541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/03/2020
• 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: 65 YR