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

Model Number	7055-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	12/23/2015
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 fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is a malpositioned implant breaching the neuroforamen.
Event or Problem Description
In (b)(6) 2015, the patient underwent a right side si joint arthrodesis where three implants were placed.The patient complained of radicular leg pain down her right side following the procedure.A ct scan showed that an implant had breached the neuroforamen causing radicular pain.In (b)(6) 2015, the surgeon performed a revision surgery where he removed the breaching implant and then added a shorter implant in a more anterior position.The explant hole was not filled with bone graft.The status of the patient following the revision surgery is not yet known.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 2066
• MDR Report Key: 5370029
• Report Number: 3007700286-2015-00114
• Device Sequence Number: 18993937
• Product Code: OUR
• UDI-Device Identifier: 00859256003316
• UDI-Public: 00859256003316
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/13/2016

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: 06/30/2019
• Device Model Number: 7055-90
• Device Lot Number: I0A30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2016
• 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: 49 YR