Fortex Pedicle Screw System X022-0096Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697X02200961), received between Aug 28, 2020 and Nov 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

Recent adverse event reports

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

• MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent

  THE COMPANY RECEIVED NOTIFICATION ON 10/09/2020 FROM A FOREIGN DISTRIBUTOR THAT REPORTED A PRODUCT COMPLAINT THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT TWO SYSTEM FINAL LOCKING CAPS WOULD NOT LOCK INTO THE THREADING OF TWO SYSTEM PEDICLE SCREW. THE COMPLAINANT STATED THAT, "IT APPEARS THAT THE THREAD ON THE SCREW HEAD AND/OR LOCKING CAP IS DAMAGED/FAULTY." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE COMPLAINT PEDICLE SCREW AND CAPS WERE REMOVED AND REPLACED WITHOUT INCIDENT. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00025, 3005031160-2020-00029, 3005031160-2020-00031.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10802935 ↗
• MalfunctionAug 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FROM A FOREIGN DISTRIBUTOR REGARDING A PRODUCT COMPLAINT FROM A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. THE COMPLAINANT REPORTED THAT THE THREADING ON A PEDICLE SCREW AND PEDICLE SCREW CAP WERE STRIPPED WHEN FINAL TIGHTENING THE CAP AFTER ROD INTRODUCTION WAS PERFORMED. THE COMPLAINT PEDICLE SCREW AND CAP WERE REMOVED AND REPLACED WITH ALTERNATE DEVICES WITH NO FURTHER ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10466059 ↗

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