Irix-C Cervical Integrated Fusion SystemRecalls & reported problems across all models
Xtant Medical Holdings, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 11 models of Irix-C Cervical Integrated Fusion System by Xtant Medical Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2018 and Aug 7, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Irix-C Cervical Integrated Fusion System problems
Device problems
- Material Fragmentation9
- Fracture6
- Break3
- Material Twisted/Bent2
- Solder Joint Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient1
Irix-C Cervical Integrated Fusion System models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 4 reports
- 3 reports
- 3 reports
- 2 reports
- 2 reports
- 2 reports
- 1 report
- 1 report
- 1 report
- 1 report
- Irix-C Cervical Integrated Fusion System X066-161307L-PCIntervertebral fusion device with integrated fixation, cervical1 report
Recent Irix-C Cervical Integrated Fusion System adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 1, 2025Fracture; Fracture
IT WAS REPORTED THAT A 7/8MM TRIAL FAILED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942442 ↗MalfunctionFeb 23, 2024Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/24/2024. IT WAS REPORTED THAT THE INTERNAL SHAFT OF A SYSTEM SCREW REMOVAL TOOL MALFUNCTIONED DURING A SURGICAL PROCEDURE. THE COMPLAINT SOURCE STATED, "WHEN THE SURGEON WAS TRYING TO BACK OUT A SCREW THAT WAS TOO LONG, THE TOP HALF OF THE INNER SHAFT SNAPPED OFF." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLIANT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 1/25/2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18768792 ↗MalfunctionApr 4, 2023Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT A FORCEPS IMPLANT INSERTER WAS BROKEN WHEN IMPACTED WITH A MALLET FOR INSERTION OF A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/13/2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16677650 ↗MalfunctionNov 17, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION ON 10/24/2022 OF A SYSTEM IMPLANT INSERTER THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT A DISTAL ARM OF THE IMPLANT INSERTER FRACTURED WHILE PLACING A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGEON USED HOSPITAL INSTRUMENTATION TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/28/2022 FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15819719 ↗MalfunctionOct 26, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED AND BECAME AWARE OF TWO UNEXPECTED MALFUNCTIONED SYSTEM AWLS ON 10/04/2022. THERE WERE NO CURRENT COMMUNICATIONS OR OPEN COMPLAINT INVESTIGATIONS FOR THESE RETURNED INSTRUMENTS. EMAIL COMMUNICATIONS WERE MADE WITH THE COMPLAINANT, WHO STATED THAT THE RETURNED INSTRUMENTS HAD PREVIOUSLY BEEN ADDRESSED THROUGH THE COMPLAINT MANAGEMENT SYSTEM. THE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE INSTRUMENTS HAD BEEN PREVIOUSLY REPORTED BY THE COMPLAINANT. THE COMPLAINANT STATED THAT THE TWO SYSTEM AWLS BOTH MALFUNCTIONED DURING PROCEDURES AND CONFIRMED THAT NEITHER MALFUNCTION RESULTED IN ANY PATIENT COMPLICATIONS. NO OTHER INFORMATION ON THE SYSTEM AWL MALFUNCTIONS WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677732 ↗MalfunctionOct 26, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED AND BECAME AWARE OF TWO UNEXPECTED MALFUNCTIONED SYSTEM AWLS ON (B)(6) 2022. THERE WERE NO CURRENT COMMUNICATIONS OR OPEN COMPLAINT INVESTIGATIONS FOR THESE RETURNED INSTRUMENTS. EMAIL COMMUNICATIONS WERE MADE WITH THE COMPLAINANT, WHO STATED THAT THE RETURNED INSTRUMENTS HAD PREVIOUSLY BEEN ADDRESSED THROUGH THE COMPLAINT MANAGEMENT SYSTEM. THE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE INSTRUMENTS HAD BEEN PREVIOUSLY REPORTED BY THE COMPLAINANT. THE COMPLAINANT STATED THAT THE TWO SYSTEM AWLS BOTH MALFUNCTIONED DURING PROCEDURES AND CONFIRMED THAT NEITHER MALFUNCTION RESULTED IN ANY PATIENT COMPLICATIONS. NO OTHER INFORMATION ON THE SYSTEM AWL MALFUNCTIONS WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677731 ↗MalfunctionOct 18, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION ON 9/22/2022 OF A SYSTEM AWL THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. A REPLACEMENT INSTRUMENT WAS PROVIDED TO THE COMPLAINANT AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/04/2022 FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15620973 ↗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 ↗MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation
THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 FOR AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THE COMPLAINANT REPORTED THAT WHILE A SURGEON WAS REMOVING A SYSTEM SCREW, THE DISTAL TIP OF A SCREW REMOVAL INSTRUMENT FRACTURED. THERE WERE NO DEFICIENCIES IDENTIFIED WITH THE SYSTEM IMPLANT OR SCREW. THE SCREW WAS REMOVED BECAUSE THE NEUROMONITORING MACHINE IDENTIFIED A LOSS IN MEP SIGNALS AND THE SURGEON WANTED TO CONFIRM THAT THERE WAS NO OBSTRUCTION TO THE SPINAL CORD. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00006.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11760706 ↗MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation
THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 FOR AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THE COMPLAINANT REPORTED THAT WHILE PREPARING TO IMPLANT A REMOVED SYSTEM SCREW, THE DISTAL TIP OF A SYSTEM AWL FRACTURED. THERE WERE NO DEFICIENCIES IDENTIFIED WITH THE SYSTEM IMPLANT OR SCREW. THE SCREW WAS REMOVED BECAUSE THE NEUROMONITORING MACHINE IDENTIFIED A LOSS IN MEP SIGNALS AND THE SURGEON WANTED TO CONFIRM THAT THERE WAS NO OBSTRUCTION TO THE SPINAL CORD. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00005.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11760704 ↗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 ↗MalfunctionApr 3, 2020Fracture; Fracture
ON (B)(6) 2020 THE COMPANY RECEIVED A COMMUNICATION FROM A DISTRIBUTOR THAT A CRACK WAS IDENTIFIED ON AN INSTRUMENT. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2020 THE COMPLAINANT NOTICED THAT THE INSTRUMENT WAS NOT HOLDING THE IMPLANT WELL AND IDENTIFIED THE CRACK. IT IS UNKNOWN HOW THE CRACK PROPAGATED ON THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A GENERAL HOSPITAL INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9924463 ↗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 ↗
Other Xtant Medical Holdings, Inc. products
All Xtant Medical Holdings, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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