Fortex Pedicle Screw System X010-0151Recalls & reported problems
Xtant Medical Holdings, Inc. · 5.5mm Cannulated Tap · Class 2
All models of Fortex Pedicle Screw System (14)
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 M697X01001511), received between Jan 7, 2019 and Dec 27, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2023Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/28/2023. IT WAS REPORTED THAT A SYSTEM 5.5MM CANNULATED TAP MALFUNCTIONED WHILE BEING USED IN A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT DUE TO BEING DISCARDED AT THE SURGICAL FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18404973 ↗MalfunctionJan 7, 2019Fracture; Fracture
THE COMPLAINANT REPORTED THAT A TAP BROKE DURING A TLIF LEFT L4/5, L5/S1 SURGERY ON (B)(6) 2018. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WERE NO KNOWN PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8223807 ↗
Other Orthosis, spinal pedicle fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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