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

Model Number SEE SECTION H.10

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651); Test Result (2695)

Event Date 04/28/2015

Event Type  Injury  

Event Description

In (b)(6) 2013, the patient underwent a right side ifuse si joint arthrodesis where three ifuse implants were placed.The patient had good pain relief for a year but then had a recurrence of pain symptoms.The surgeon thought he saw lucency around the implants and decided to remove them.In (b)(6) 2015, the surgeon attempted to remove the implants but was unable to remove them because they fixed solidly in bone and could not be removed even with heavy malleting using the implant removal tool.The surgeon ultimately left the implants in place and decorticated the joint then added bone graft.The condition of the patient following the surgery is not yet known.

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 for the recurrence of pain could not be determined.Part numbers, lot numbers, manufacturing dates (if available) and expiration dates: ifuse implant, p/n 7045-90, lot# i0500, manufactured 08/02/13, expires 2018-04; ifuse implant, p/n 7045-90, lot# i0500, manufactured 08/02/13, expires 2018-04; ifuse implant, p/n 7035-90, lot# i0374, manufactured 06/27/13, expires 2018-01.

• 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: 4746743
• MDR Text Key: 5826492
• Report Number: 3007700286-2015-00036
• 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: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Other Device ID Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• 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: 37 YR