Irix-C Cervical Integrated Fusion System T066-0205Recalls & reported problems
Xtant Medical Holdings, Inc. · Guided Angled Awl · Class 1 · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M697T06602051), received between Jul 12, 2018 and May 20, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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.
Most reported problems
Device problems
- Material Fragmentation2
- Break1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM INSTRUMENT MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM AWL FRACTURED WHILE PREPARING PATIENT BONE FOR IMPLANT PLACEMENT DURING A PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT AWL WAS RECEIVED ON (B)(6) 2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14456977 ↗MalfunctionSep 19, 2019Fracture; Fracture
THE COMPLAINANT REPORTED THAT DURING AN ACDF REVISION DUE TO NONUNION, A FORCEPS IMPLANT INSERTER AND A GUIDED ANGLED AWL WERE BROKEN. THE INITIAL SURGERY WAS REPORTEDLY A NON-X-SPINE PRODUCT. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THE INSTRUMENT MALFUNCTIONS. THE FOLLOWING MDRS CORRESPOND TO THIS EVENT: 3005031160-2019-00044.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9088044 ↗MalfunctionJul 12, 2018Break; Material Fragmentation; Break; Material Fragmentation
THE COMPLAINANT REPORTED TO THE COMPANY THAT A GUIDED ANGLED AWL TIP BROKE INSIDE A CAGE DURING SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7681901 ↗
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 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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