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

Model Number 7050-90

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 03/13/2015

Event Type  Injury  

Event Description

In (b)(6) 2015, the patient underwent a right side ifuse si joint arthrodesis where three ifuse implants were placed.The patient complained of leg pain after the initial surgery.A ct scan revealed that the most superior implant was slightly breaching the neuroforamen.In (b)(6) 2015, the surgeon performed a revision surgery where he removed the most superior implant that had breached the neuroforamen.The status of the patient following the procedure is not yet known.

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 for the complaint is a malpositioned implant impinging on the nerve root.

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 206
• Manufacturer (Section G): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 206
• Manufacturer Contact: w. reckling, m.d. ; 3055 olin avenue; suite 2200; san jose, CA 95128-2066 ; 4082070700
• MDR Report Key: 4614590
• MDR Text Key: 16173797
• Report Number: 3007700286-2015-00023
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 7050-90
• Device Lot Number: I09198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR