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

Model Number SEE SECTION H.10

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 11/03/2014

Event Type  Injury  

Event Description

In (b)(6) 2013, the patient had a right side si joint fusion where three ifuse implants were placed.The patient later experienced back pain.A ct scan revealed that an implant may have been positioned too posterior.In (b)(6) 2014, a new surgeon performed a revision surgery where he tried to remove the implant but it was solidly in bone and could not be removed.He instead added two additional implants to help fixate the si joint.

Manufacturer Narrative

Based on the information provided, review of the surgical technique guide, ifu, certificates of conformance and fmea, there is no evidence that the device was out of specification.The most probable root cause for the revision is insufficient si joint fixation and a malpositioned implant.Part, part numbers, lot numbers, manufacturing dates and expiration dates: ifuse implant, p/n 7035-90, lot# 8175003938011, manufactured 09/01/12, expires 2015-10; ifuse implant, p/n 7045-90, lot# i0833, manufactured 10/14/13, expires 2018-09; ifuse implant, p/n 7050-90, lot# i0303, manufactured 04/04/13, 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: 4252260
• MDR Text Key: 15914304
• Report Number: 3007700286-2014-00119
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• 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: EXP. DATES - SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• 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: 44 YR