Fortex Pedicle Screw System X070-0040Recalls & reported problems
Xtant Medical Holdings, Inc. · Cross Connector, Locking Driver · Class 2
All models of Fortex Pedicle Screw System (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M697X07000401), received between Mar 26, 2018 and Jul 22, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT A LEVEL ADJACENT TO AN EXISTING POSTERIOR FIXATION CONSTRUCT. DURING THE REMOVAL OF A CROSS LINK, IT WAS NOTED THAT THE DISTAL TIP OF THE CROSS LINK DRIVER FRACTURED OFF. NO PIECES WERE RETAINED BY THE PATIENT. A SPARE DRIVER WAS USED TO FINISH THE REMAINDER OF THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801357 ↗MalfunctionJun 8, 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 SCREWDRIVER FRACTURED WHILE ATTEMPTING TO REMOVE A SYSTEM SCREW FROM AN ALTERNATE MANUFACTURER. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 6/03/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14639066 ↗MalfunctionMar 10, 2021Material Fragmentation; Material Fragmentation
THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2021 THAT THE DISTAL TIP OF A SYSTEM DRIVER FRACTURED WHEN TIGHTENING A SYSTEM SCREW DURING A L4-L5 PLIF PROCEDURE. THE FRACTURED PORTION OF THE DRIVER WAS IMMEDIATELY REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11457576 ↗MalfunctionOct 16, 2018Fracture; Fracture
THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF A LOCKING DRIVER BROKE WHILE A SURGEON WAS TRYING TO REMOVE A SET SCREW OF A CROSS CONNECTOR. THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7970179 ↗MalfunctionMar 26, 2018Fracture; Fracture
THE COMPLAINANT CONTACTED THE COMPANY REGARDING A POSSIBLE COMPLAINT. PER THE COMPLAINANT, "WE HAD A DRIVER TIP BREAK OFF DURING SURGERY. NO HARM WAS DONE TO THE PATIENT AND IT DID NOT DELAY THE CASE AT ALL."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7372059 ↗
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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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