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Fortex Pedicle Screw System N60001073Recalls & reported problems

Xtant Medical Holdings, Inc. · 5.5mm Diameter x 35mm Rod · Class 2 · Implant

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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697N600010731), received between Dec 20, 2019 and Dec 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K090224, K120832, K152132); they may or may not involve this specific model.

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

  • Patient Device Interaction Problem2

Patient problems

  • Pain2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    A COMPLAINANT COMMUNICATED ON (B)(6) 2019 THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 DUE TO NON-FUSION AND POTENTIAL LOOSENING HARDWARE. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00057, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00062, 3005031160-2019-00063.

    Patient problems: Pain

    MAUDE report 9508001 ↗
  • InjuryDec 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    A COMPLAINANT COMMUNICATED ON 11/22/2019 THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 DUE TO NON-FUSION AND POTENTIAL LOOSENING HARDWARE. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00056, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00062, 3005031160-2019-00063.

    Patient problems: Pain

    MAUDE report 9507999 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090224, K120832, K152132. One submission often covers many models, so check the product and lot details in each record.

  • Z-1773-2026 · Feb 18, 2026 · Open, Classified
    XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
  • Z-1884-2017 · Apr 12, 2017 · Terminated
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Stra
  • Z-1823-2015 · Apr 7, 2015 · Terminated
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
  • Z-1512-2015 · Mar 11, 2015 · Terminated
    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar con

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Sources and updates

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