Irix-C Cervical Integrated Fusion System T066-0059Recalls & reported problems
Xtant Medical Holdings, Inc. · Forceps Inserter · 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 M697T06600591), received between May 26, 2020 and May 26, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Solder Joint Fracture” (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
- Solder Joint Fracture2
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.
MalfunctionMay 26, 2020Solder Joint Fracture; Solder Joint Fracture
THIS MEDICAL DEVICE REPORT IS ASSOCIATED WITH MDR NUMBER 3005031160-2020-00013, WHERE IT WAS REPORTED THAT A FORCEPS IMPLANT INSERTER MALFUNCTIONED WHILE IN USE. THE COMPLAINANT ASSESSED A SECOND FORCEPS INSERTER (FROM THE SAME LOT) AND FOUND THAT THE SAME FAILURE WAS ACHIEVED WITH MINIMAL FORCE APPLIED BY HAND. THE SECOND MALFUNCTION WAS NOT REPORTEDLY INVOLVED IN A SURGICAL PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10089906 ↗MalfunctionMay 26, 2020Solder Joint Fracture; Solder Joint Fracture
THE COMPANY RECEIVED NOTIFICATION ON 5/05/2020 REGARDING A FORCEPS IMPLANT INSERTER THAT WAS REPORTED TO HAVE THE IMPACTION PLATE FRACTURE FROM THE INSTRUMENT WITH MINIMAL STRIKING FORCE DURING A SURGICAL PROCEDURE ON (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE COMPLAINANT ASSESSED A SECOND FORCEPS INSERTER (FROM THE SAME LOT) AND FOUND THAT THE SAME FAILURE WAS ACHIEVED WITH MINIMAL FORCE APPLIED BY HAND. REPORT 3005031160-2020-00014 HAS BEEN SUBMITTED FOR THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10089904 ↗
Other Impactor devices
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- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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