Irix-C Cervical Integrated Fusion System T066-0086Recalls & reported problems
Xtant Medical Holdings, Inc. · 14mm, Fixed Angle Drill Tip · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697T06600861), received between Jul 3, 2019 and Jul 3, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 Twisted/Bent2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2019Material Twisted/Bent; Material Twisted/Bent
THE COMPLAINANT REPORTED THAT TWO DRILL BITS BENT UPON REMOVAL AFTER PILOTING HOLES DURING SURGERY. THE INSTRUMENT KITS CONTAINED TWO DRILL BITS AND THE SURGERY WAS SUCCESSFUL WITH THE TWO DRILL BITS. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00031.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8761277 ↗MalfunctionJul 3, 2019Material Twisted/Bent; Material Twisted/Bent
THE COMPLAINANT REPORTED THAT TWO DRILL BITS BENT UPON REMOVAL AFTER PILOTING HOLES DURING SURGERY. THE INSTRUMENT KITS CONTAINED TWO DRILL BITS AND THE SURGERY WAS SUCCESSFUL WITH THE TWO DRILL BITS. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00032.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8761276 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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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