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 Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2022.It was reported that a system implant screw was identified as having backed out post-operatively.No other information was initially available, and requests for relevant complaint incident information were made on (b)(6) 2022, (b)(6) 2022, (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023.
Additional Manufacturer Narrative
It cannot be determined how or why the implant screw reportedly backed out post-operatively.A dhr review could not be performed due to the lot number of the complaint device not being available.If/or when there is relevant complaint incident information available, the complaint investigation and any associated regulatory reporting will be updated.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.
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.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 have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.This report is associated with 3005031160-2022-00044, submitted on 1/11/2023.
Event or Problem Description
The manufacturer was made aware of a product complaint on 12/12/2022.It was reported that a system implant screw was identified as having backed out post-operatively.No other information was initially available, and requests for relevant complaint incident information were made on 12/12/2022, 12/16/2022, 12/28/2022, 1/04/2023, and 1/09/2023.On 1/12/2023 a response was received from the complainant which identified the device part/lot numbers as well as the revision surgery and patient health status.The reported implant deficiency was identified on (b)(6) 2022 by fluoroscopic imaging for a l4-s1 360 procedure performed on (b)(6) 2022.A revision procedure was performed on (b)(6) 2022 in which the implant screws were reseated, and a plate was placed over the implant.The complainant reported that the health status of the patient was good after the revision procedure.This report is associated with 3005031160-2022-00044, submitted on 1/11/2023.

• 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: 16141950
• Report Number: 3005031160-2022-00044
• Device Sequence Number: 6661005
• 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,Followup
• Report Date (Section B): 01/19/2023

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: 059710
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/19/2023
• 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 Age: 78 YR
• Patient Sex: Female