MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X080-5525SD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was performed for the complaint device lot and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 5/19/2017.The root cause of this complaint cannot be reliably determined.It may be possible for the implant screws of the implant spacer to back out after being placed if they were not adequately placed to be retained by the locking arms of the implant spacer.The system surgical technique guide provides guidance on appropriate screw angulation and states, "visual confirmation of the locking arm over the screw and the screw's full seating in the faceplate should be performed." there are also two cautionary statements in the screw insertion section that state, "over-angulation of the screw beyond 3 degrees in any direction may result in failure of the screw to engage the implant and/or locking arm." and "failure to confirm that the locking arm is in front of the screw may result in early or late screw loosening." there has been one other complaint of similar nature in the past 12 months, which was received from the same report source.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint on 2/02/2023.It was reported that system implant screws were identified as having backed out post-operatively.The health status of the patient was reported as good, and that a revision procedure would be performed.Requests for available surgical and post-operative images were made, although there were none available for assessment.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 16469752
• Report Number: 3005031160-2023-00002
• Device Sequence Number: 14735835
• Product Code: OVD
• UDI-Device Identifier: M697X0805525SD1
• UDI-Public: M697X0805525SD1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X080-5525SD
• Device Lot Number: 059170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown