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

Device Problems Break (1069); Malposition of Device (2616); Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer for evaluation.

Event Description

An alif was performed at l5, date not provided.Discovered upon follow-up visit, at unknown date, the patient experienced a screw backout and breakage.Surgeon decided to not perform any additional surgery as patient is not in any pain.

• Brand Name: IRIX-A LUMBAR 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: kriss anderson ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6172533
• MDR Text Key: 62675835
• Report Number: 3005031160-2016-00099
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133947
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2016
• Initial Date FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other