Fortex Pedicle Screw System X022-0161Recalls & reported problems
Xtant Medical Holdings, Inc. · Final Locking Cap Driver Assembly · Class 2
All models of Fortex Pedicle Screw System (14)
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 M697X02201611), received between Apr 19, 2018 and Feb 7, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 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 Fragmentation3
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2020Material Fragmentation; Material Fragmentation
THE COMPLAINANT REPORTED THAT DURING A LUMBAR ARTHRODESIS PROCEDURE ON (B)(6) 2020, THE DISTAL TIP OF A FINAL LOCKING CAP DRIVER WAS BROKEN. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THIS INSTRUMENT MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9683945 ↗MalfunctionJul 12, 2018Material Fragmentation; Material Fragmentation
THE COMPLAINANT REPORTED TO THE COMPANY THAT A DRIVER BROKE DURING SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7681893 ↗MalfunctionApr 19, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE COMPLAINANT REPORTED THAT THE SUGEON WAS PERFORMING THE FINAL LOCK AND THE DRIVER BROKE INSIDE THE FORTEX LOCKING CAP. THE SURGEON WAS ABLE TO REMOVE THE BIT THAT BROKE OFF FROM THE LOCKING CAP AND PERFORMED THE FINAL LOCK WITH A NORMAL LOCKING DRIVER. THE COMPLAINANT CONFIRMED THAT THERE WAS NO HARM DONE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7444611 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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.
How reports and recalls are matched · Editorial policy · Report an error on this page