Fortex Pedicle Screw System X022-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M697X02202401), received between Mar 29, 2018 and Apr 24, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Fracture

  THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON (B)(6) 2026. IT WAS REPORTED THAT THE DISTAL THREADING OF A PEDICLE SCREWDRIVER ASSEMBLY WAS DAMAGED, WHICH RESULTED IN A SYSTEM SCREW BEING STUCK ON THE DRIVER. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAYS IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATIVE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A REPLACEMENT INSTRUMENT WAS PROVIDED, AND AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984024 ↗
• MalfunctionSep 14, 2023Break; Break

  THE MANUFACTURER WAS MADE AWARE OF PRODUCT COMPLAINTS ON (B)(6) 2023. IT WAS REPORTED THAT A SYSTEM PEDICLE SCREWDRIVER AND TORQUE HANDLE WERE IDENTIFIED AS BROKEN AND REQUESTED TO BE REPLACED. THE COMPLAINANT STATED THAT THEY WERE INFORMED, "THE DRIVER JUST FELL APART AFTER IT WAS NOT WORKING PROPERLY THEN THE TOP CAME APART.", AND THE "TORQUE HANDLE HAD A DRIVER STUCK IN IT AND AS I WAS PULLING IT APART IT BROKE." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH AS OF (B)(6) 2023 HAVE NOT BEEN RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. ADDITIONAL ATTEMPTS TO GATHER RELEVANT COMPLAINT INCIDENT INFORMATION AND CONFIRM RETURN OF THE COMPLAINT INSTRUMENTS WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750291 ↗
• MalfunctionApr 19, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 3/22/2022. IT WAS REPORTED THAT THE SYSTEM SCREWDRIVER WAS NOT IN FUNCTIONAL CONDITION DUE TO WORN THREADING AND WAS REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 3/30/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14148603 ↗
• MalfunctionDec 13, 2021Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/18/2021. IT WAS REPORTED THAT THE DISTAL THREADS OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING USED IN A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 11/24/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984798 ↗
• MalfunctionJun 23, 2021Fracture; Fracture

  THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2021 FOR A SYSTEM SCREWDRIVER THAT WAS REPORTED TO NOT FUNCTION AS INTENDED DUE TO HAVING A WORN SQUARE THREAD DETAIL AND WAS REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE COMPANY FOR COMPLAINT ASSESSMENT ON 6/04/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050414 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT A GRIP SET SCREW ON A SCREWDRIVER BROKE DURING SURGERY. AN ALTERNATE SCREWDRIVER WAS AVAILABLE AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9380024 ↗
• MalfunctionNov 25, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT WHILE IMPLANTING A PEDICLE SCREW, THE THREADED PORTION OF THE PEDICLE SCREWDRIVER PARTIALLY BROKE. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372795 ↗
• MalfunctionAug 6, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT TWO WING LOCK PEDICLE SCREWDRIVERS WERE DAMAGED DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE FOLLOWING MDR NUMBERS ARE ASSOCIATED WITH THIS EVENT. 3005031160-2019-00037.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864745 ↗
• MalfunctionAug 6, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT TWO WING LOCK PEDICLE SCREWDRIVERS WERE DAMAGED DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE FOLLOWING MDR NUMBERS ARE ASSOCIATED WITH THIS EVENT. 3005031160-2019-00038.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864742 ↗
• MalfunctionAug 6, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE GRIP SET SCREW ON TOP OF THE WING LOCK PEDICLE SCREWDRIVER BROKE DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DRIVER FROM THE SURGICAL SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864508 ↗
• MalfunctionFeb 11, 2019Material Fragmentation; Material Fragmentation

  THE COMPLAINANT STATED THAT THE THREADS ON A PEDICLE SCREWDRIVER WERE WEARING AWAY. THE DAMAGE WAS REPORTED TO HAVE HAPPENED WHILE TRYING TO DISENGAGE A PEDICLE SCREW FROM THE SCREWDRIVER AFTER IMPLANTATION. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327324 ↗
• MalfunctionFeb 11, 2019Material Fragmentation; Material Fragmentation

  THE COMPLAINANT STATED THAT THE THREADS ON A PEDICLE SCREWDRIVER WERE WEARING AWAY. THE DAMAGE WAS REPORTED TO HAVE HAPPENED WHILE TRYING TO DISENGAGE A PEDICLE SCREW FROM THE SCREWDRIVER AFTER IMPLANTATION. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327295 ↗
• MalfunctionFeb 11, 2019Material Fragmentation; Material Fragmentation

  DURING SURGERY, THE SURGEON SUCCESSFULLY IMPLANTED A PEDICLE SCREW. THE SURGEON EXPERIENCED DIFFICULTY WHEN TRYING TO DISENGAGE THE PEDICLE SCREW FROM THE SCREWDRIVER. THE COMPLAINANT SUSPECTED THAT THE SCREW HAD BECOME CROSS-THREADED. THE SURGEON WAS ABLE TO DISENGAGE THE SCREWDRIVER, HOWEVER, THE THREADS ON THE DRIVER FRACTURED OFF UPON DISENGAGEMENT. THE SCREW WAS UNDAMAGED, AND THE SCREW CAP WAS PLACED WITH NO ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327250 ↗
• MalfunctionMar 29, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE COMPLAINANT REPORTED TO THE COMPANY THAT THE WING LOCK PEDICLE SCREWDRIVER'S THREAD DISINTEGRATED DURING THE PROCEDURE. THERE ARE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381959 ↗
• MalfunctionMar 29, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE COMPLAINANT NOTIFIED THE COMPANY THAT THE WING LOCK PEDICLE SCREWDRIVER'S THREAD DISINTEGRATED DURING SURGERY. THERE ARE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381948 ↗