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

Model Number	4040-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu 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 implants.
Event or Problem Description
The patient had right side si joint arthrodesis sometime in 2014 where two implants were installed.In (b)(6) 2014, the patient had an additional procedure where two additional implants of the same type were added to the right si joint for additional fixation.The surgeon later decided to remove all the implants.The surgeon did not offer a reason for the removal and did not indicate that the implants were loose or malpositioned.Imaging did not appear to show malpositioning or lucency.In (b)(6) 2019, the surgeon removed all the implants with chisels as they were solidly fix in bone.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: 8634015
• Report Number: 3007700286-2019-00062
• Device Sequence Number: 11351260
• Product Code: OUR
• UDI-Device Identifier: 00859256003415
• UDI-Public: 00859256003415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: 09/05/2015
• Device Model Number: 4040-90
• Device Lot Number: 8029003804003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: 48 YR