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

Model Number	SEE SECTION H.10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique guide, certificates of analysis, ifu and fmeas, the most probable root cause for the infection is the surgical procedure.There have been no other complaints about infections related to this implant lot.
Event or Problem Description
The patient had si joint arthrodesis in (b)(6) 2020 where one implant was installed.The patient later developed an infection at the surgical site.The patient is being treated with oral antibiotics.No surgical intervention was performed.This is a low frequency, low severity complaint (post-operative superficial wound infection).
Additional Manufacturer Narrative
The patient developed a hematoma around the surgical site.No medical intervention was noted.The hematoma has resolved.
Event or Problem Description
See section h.10.

• 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: 10197513
• Report Number: 3007700286-2020-00050
• Device Sequence Number: 19549597
• Product Code: OUR
• UDI-Device Identifier: 00851085007541
• UDI-Public: 00851085007541
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 03/05/2025
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement 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: 67 YR