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

Model Number SEE SECTION H.10

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 09/08/2014

Event Type  Injury  

Event Description

In (b)(6)2013, the surgeon performed a left side si joint fusion on the patient placing three ifuse implants.The patient did well for several months but later complained of a recurrence of low back pain.In (b)(6) 2014, the surgeon performed a revision surgery where he removed one implant that was short and replaced it with a longer one and added two additional implants to help fixate the joint.The patient's status following the procedure is unknown.

Manufacturer Narrative

Based on the information provided, review of the surgical technique guide, ifu, certificates of analysis and fmea, there is no evidence that the device was out of specification.The most probable root cause is recurrence of symptoms caused by a short implant not fully seated into the sacrum.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# 148828, manufactured 11/30/12, expires 2017-11; ifuse implant, p/n 7055-90, lot# 8078003804010, manufactured 08/10/12, expires 2015-09.

• 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: 4116094
• MDR Text Key: 19716959
• Report Number: 3007700286-2014-00099
• 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: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/08/2014
• 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