Irix-A Lumbar Integrated Fusion System X080-332611-08PC-STRRecalls & reported problems
Xtant Medical Holdings, Inc. · IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 11mm, PC (STERILE) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X08033261108PCSTR1), received between May 15, 2024 and May 15, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2024Migration; Migration
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.
Patient problems: Insufficient Information
MAUDE report 19326365 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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