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

Model Number	X080-332611-08PC-STR
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot# 054940 expiration 5/01/2021 or lot# 048663 expiration 6/01/2020.The explanted system implant screw lot number was not identified and was not available to be returned to the manufacturer for assessment.The complainant provided two possible system interbody spacer lot numbers that may have been related to this complaint.Dhr reviews were performed for both possible implant lots, which were unable to identify any manufacturing issues.Both implant lots met all required specifications prior to being released to distributable inventory.One implant lot has been available for distribution since 2/20/2015 and the other has been available for distribution since 4/14/2016.The system surgical technique guide provides guidance on appropriate screw implantation 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." the root cause of this complaint cannot be reliably determined.Without the ability to visualize the implant locking arm post operatively, no evaluation could be performed and it is unknown if the system implant screw was retained by the implant locking arm.There have not been any other complaints of similar nature with this surgical system in the past 12 months.The manufacturer will continue to monitor the field for complaints of migrated implants.There is no additional information or events related to this report.If additional information relevant to this complaint and regulatory report is received by the manufacturer, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a post operative appointment, a system implant screw was identified to have migrated from its intended position in a system interbody spacer.Xray imaging was provided which showed an inferior implant screw was extended beyond the surface of the system interbody spacer.A revision procedure was successfully completed without incident, in which the migrated system implant screw was removed.The level where the system implant screw was removed was deemed to be stable with bony fusion and required no further surgical intervention.The patient will be assessed with a standard post op protocol for an anterior approach.

• 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 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade 59714 ; 4069245878
• MDR Report Key: 19326365
• Report Number: 3005031160-2024-00010
• Device Sequence Number: 2685737
• Product Code: OVD
• UDI-Device Identifier: M697X08033261108PCSTR1
• UDI-Public: M697X08033261108PCSTR1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: X080-332611-08PC-STR
• Device Catalogue Number: N/A
• Device Lot Number: SEE H10 SUMMARY
• 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: 04/15/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Male