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

Model Number	7070M-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmeas, there is no indication of device failure and no indication that the device was out of specification.The root cause is the surgeon's decision to use a shorter implant as a precaution.
Event or Problem Description
In (b)(6) 2018, the surgeon performed a left side si joint arthrodesis on the patient placing two implants along with an iliosacral screw on a pelvis trauma case.The patient complained of continued radiculopathy that he had before the procedure.Imaging confirmed that neither of the implants had breached the neuroforamen, but the surgeon decided to remove the longer implant and replace it with a shorter implant as a precaution due to the patient's history of sciatica.Three days after the initial procedure, the surgeon performed a revision procedure where he removed the 70 mm implant and replaced it with a shorter implant, 55 mm, using the explant void.No other preexisting implants were 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: 7805379
• Report Number: 3007700286-2018-00064
• Device Sequence Number: 1536331
• Product Code: OUR
• UDI-Device Identifier: 00851085007541
• UDI-Public: 00851085007541
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 03/05/2023
• Device Model Number: 7070M-90
• Device Lot Number: 2631391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: Required Intervention
• Patient Age: 60 YR