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); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer for evaluation; still implanted in patient.Device not returned to manufacturer.

Event Description

Noncompliant patient presented at the er with a broken endplate and screws backing out and refused further surgical care; no other information is available.

• 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: 5992146
• MDR Text Key: 56100898
• Report Number: 3005031160-2016-00080
• 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: 08/31/2016

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: 08/31/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other