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

Model Number SEE SECTION H.10

Device Problems Break (1069); Difficult to Remove (1528); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Based on the information provided, review of surgical technique guide, ifu and fmea, there is no evidence that the device was out of specification.The most probable root cause for the breaking of the pin is surgical technique.Part numbers, lot numbers, manufacturing dates, expiration dates, udi numbers: ifuse implant, p/n 7055-90, lot# i0a64, manufactured 08/14/14, expires 2019-08, (b)(4); ifuse implant, p/n 7045-90, lot# 353337, manufactured 04/01/15, expires 2020-04, (b)(4); ifuse implant, p/n 7045-90, lot# 353336, manufactured 02/27/15, expires 2020-02, (b)(4); guide pin 3.2 mm, p/n 500373.Broken pin disposed of at hospital.

Event Description

In (b)(6) 2015, the surgeon performed an ifuse arthrodesis on the patient placing three implants.During the course of the procedure, the tip of a guide pin was broken off and left inside the implant when the tip struck a preexisting pedicle screw from a previous unrelated lumbar fusion.All three implants were ultimately successfully placed.The tip of the pin is safely in bone and is not impinging on the neuroforamen.The proximal portion of the pin is safely inside the implant and is not protruding into the soft tissue.The patient suffered no injury secondary to the broken pin.The patient did not require additional medical care.The current status of the patient is not yet known.

• 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: 5240709
• MDR Text Key: 31785069
• Report Number: 3007700286-2015-00095
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• 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): Other
• Patient Age: 37 YR