Irix-C Cervical Integrated Fusion System X066-161307L-PCRecalls & reported problems
Xtant Medical Holdings, Inc. · IRIX-C INTEGRATED SPACER ASSY, 16 X 13 X 7°, 7mm, PC · Class 2 · Implant
All models of Irix-C Cervical Integrated Fusion System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X066161307LPC1), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 7/17/2025. IT WAS REPORTED THAT AFTER PLACING A SYSTEM INTERBODY SPACER THE LOCKING ARM OF THE IMPLANT WOULD NOT CAPTURE AND RETAIN THE IMPLANT SCREW AS INTENDED. THE INTERBODY WAS REMOVED AND REPLACED WITH AN ALTERNATE IMPLANT, WHICH ALLOWED FOR THE IMPLANT SCREW TO LOCK INTO THE SPACER AS INTENDED. THERE WAS NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT IMPLANT AND SCREWS, WHICH ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 7/30/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738799 ↗
Other Intervertebral fusion device with integrated fixation, cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
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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