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

Model Number	7050-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, certificates of conformance, ifu and fmeas, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is user error; improper implant size selection, using an implant that were too long or not installing the implant deep enough.
Event or Problem Description
The patient had bilateral side si joint arthrodesis in (b)(6) 2019 where three implants were installed on the left side and two on the right.The patient had pain relief for four months before experiencing a recurrence of pain symptoms on the left side.The surgeon determined that the caudal positioned implant was too proud of the ilium causing pain.The surgeon did not indicate that any of the implants were loose.In (b)(6) 2019, the surgeon performed a revision procedure where he removed the caudal positioned implant using chisels as it was solidly fixed in bone.No other preexisting implants were adjusted or removed.No other hardware was installed.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 95050 4482
• MDR Report Key: 8809363
• Report Number: 3007700286-2019-00083
• Device Sequence Number: 10842890
• Product Code: OUR
• UDI-Device Identifier: 00851085007367
• UDI-Public: 00851085007367
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 12/10/2023
• Device Model Number: 7050-100
• Device Lot Number: 2658981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/19/2019
• 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: Required Intervention
• Patient Age: 37 YR