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

Model Number SEE SECTION H.10

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Device Handling Problem (3265)

Patient Problems Pain (1994); Arthralgia (2355); Joint Disorder (2373)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmea, there is no indication of implant failure and no indication that the implant or instruments were out of specification.The most probable root cause for the patient's pain symptoms could not be determined.The surgeon damaged two removal chisels during the revision surgery due to misuse.The implants were not returned for evaluation.Right side ifuse implants initially added on (b)(6) 2010.The ifuse implants were not returned for evaluation: ifuse implant, p/n 7035-90, lot# i0851, manufactured 11/22/13, expires 2018-11 (udi (b)(4)).Ifuse implant, p/n 7035-90, lot# i0492, manufactured 03/03/13, expires 2018-03 (udi (b)(4)).Ifuse implant, p/n 7030-90, lot# 8175003938010, manufactured 09/18/12, expires 2015-10 (udi (b)(4)).Chisels returned for evaluation: p/n 500260-b, chisel, removal system, 2 blade (lot n35818).P/n 500260-b, chisel, removal system, 2 blade (lot n35819).Chisel engineering evaluation summary: the chisels were not aligned properly with the implants before being struck with the mallet.The edges of the chisels were damaged by contacting the implants.

Event Description

In (b)(6) 2014, the patient underwent a right side si joint arthrodesis where three ifuse implants were placed.The patient presented to a different surgeon in (b)(6) 2015 with pain complaints and requesting that the implants be removed.In (b)(6) 2015, the surgeon performed a revision surgery where all three implants were removed.During the procedure, the surgeon attempted to use ifuse implant removal chisels to remove the implants but was unable to position the chisels correctly and ended up damaging the blade of the chisels on the implant.According to the surgeon, the patient is "doing fine" following the procedure.

• 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 2066
• Manufacturer (Section G): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 2066
• Manufacturer Contact: w. reckling, m.d. ; 3055 olin avenue; suite 2200; san jose, CA 95128-2066 ; 4082070700
• MDR Report Key: 5185782
• MDR Text Key: 29775067
• Report Number: 3007700286-2015-00086
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 62 YR