MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number X066-161306P-PC

Device Problem Device Damaged by Another Device (2915)

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

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

The root cause is undetermined due to lack of information, no device returned for investigation.The complaint of the locking mechanism not engaging properly could not be confirmed.

Event Description

An irix-c standalone cervical interbody implant was placed at c4-5 region of the cervical spine.The surgeon reported using the angled drill guide.The first screw was placed in the cranial direction at a 38 degree angle using the guide and locked into place properly.The second screw was placed in the caudal direction at a 38 degree angle using the guide.After the screw was placed, the guide was removed, and upon examination, the locking mechanism had not engaged properly.There were multiple attempts to seat the screw deeper into the implant and engage the mechanism.This second screw was removed and the implant was left as it still provided proper height.After this, the surgeon chose to go with a standard titanium coated peek implant at the c5-6 level with a plate.After performing another discectomy, the standard interbody implant was placed with no complications.No injuries were reported.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: charlene brumbaugh ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6789998
• MDR Text Key: 82673832
• Report Number: 3005031160-2017-00152
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: X066-161306P-PC
• Device Lot Number: 058329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR