Certex Spinal Fixation System X067-0440Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M697X06704401), received between Apr 27, 2018 and Sep 9, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON (B)(6) 2022 OF A SYSTEM SCREWDRIVER THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL THREADING OF THE SCREWDRIVER FRACTURED WHEN A SYSTEM IMPLANT SCREW WAS OVERTIGHTENED ONTO THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393306 ↗
• MalfunctionDec 3, 2021Fracture; Fracture

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/04/2021. IT WAS REPORTED THAT THE DISTAL SQUARE THREAD DETAIL OF A SYSTEM SCREWDRIVER FRACTURED WHILE TIGHTENING A SYSTEM SCREW. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 12/01/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925527 ↗
• MalfunctionDec 3, 2021Fracture; Fracture

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/04/2021. IT WAS REPORTED THAT THE DISTAL SQUARE THREAD DETAIL OF A SYSTEM SCREWDRIVER FRACTURED WHILE TIGHTENING A SYSTEM SCREW. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 12/01/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925387 ↗
• MalfunctionSep 30, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 9/09/2020 FROM A DISTRIBUTOR REQUESTING REPLACEMENT OF TWO SYSTEM SCREWDRIVERS. IT WAS REPORTED THAT THE THREAD DETAIL AT THE DISTAL TIP OF TWO SYSTEM SCREWDRIVERS WERE DEFECTIVE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS APPROXIMATELY A 10-MINUTE DELAY WHILE ALTERNATE INSTRUMENTS WERE GATHERED, WHICH WERE 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 9/24/2020. REPORT #3005031160-2020-0024 IS ASSOCIATED WITH THIS SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610682 ↗
• MalfunctionSep 30, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 9/23/2020 FROM A DISTRIBUTOR REGARDING A SCREWDRIVER MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT THE THREAD DETAIL AT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE IMPLANTING A SYSTEM SCREW. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE INSTRUMENT WAS AVAILABLE, WHICH 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 9/30/2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610680 ↗
• MalfunctionSep 30, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 9/09/2020 FROM A DISTRIBUTOR REQUESTING REPLACEMENT OF TWO SYSTEM SCREWDRIVERS. IT WAS REPORTED THAT THE THREAD DETAIL AT THE DISTAL TIP OF TWO SYSTEM SCREWDRIVERS WERE DEFECTIVE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS APPROXIMATELY A 10-MINUTE DELAY WHILE ALTERNATE INSTRUMENTS WERE GATHERED, WHICH WERE 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 9/24/2020. REPORT #3005031160-2020-0021 IS ASSOCIATED WITH THIS SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610679 ↗
• MalfunctionNov 25, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE THREADS OF A SCREWDRIVER BROKE WHILE ENGAGED WITH A SYSTEM SCREW DURING SURGERY. AN ALTERNATE DRIVER WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO DELAYS AND NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372786 ↗
• MalfunctionMay 31, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT A TECHNICIAN PLACED A 3.5X10MM SCREW ON THE DISTAL END OF EACH SCREWDRIVER. THE SURGEON REQUESTED A DIFFERENT SIZE SCREW. THE SCREW WAS UNABLE TO BE REMOVED FROM ONE OF THE SCREWDRIVERS. THE TECHNICIAN SET ASIDE THE SCREWDRIVER AND USED THE OTHER SCREWDRIVER THAT WAS AVAILABLE. WHEN THE TECHNICIAN WAS ABLE TO INSPECT THE DEFECTIVE SCREWDRIVER, IT WAS NOTICED THAT THE THREAD THAT ENTERS THE SCREW WAS BROKEN. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8661033 ↗
• MalfunctionApr 16, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT A SCREWDRIVER BROKE WHEN THE SURGEON WAS DISENGAGING THE SCREW FROM THE DRIVER. AN ALTERNATE SCREWDRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8519908 ↗
• MalfunctionNov 29, 2018Material Fragmentation; Material Fragmentation

  THE COMPLAINANT REPORTED TO THE COMPANY, THAT A SCREWDRIVER BROKE AT THE THREADS ON THE OUTER SLEEVE AND REQUESTED THAT THE SCREWDRIVER BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8117718 ↗
• MalfunctionMay 23, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE COMPLAINANT REPORTED THAT WHILE TRYING TO INSERT A SCREW, IT WOULD NOT DISENGAGE FROM THE DRIVER. ONCE THE SCREW AND DRIVER WERE REMOVED FROM THE SURGICAL AREA, IT WAS DISCOVERED THAT A PORTION OF THE DISTAL TIP OF THE SCREWDRIVER WAS BROKEN. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538708 ↗
• MalfunctionApr 27, 2018Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE SURGEON ATTEMPTED TO PLACE A 3.5MM CERTEX SCREW IN THE CERVICAL SPINE AND THE SCREW WOULD NOT DISENGAGE FROM THE DRIVER. THE SCREW WAS THEN EXPLANTED. WHEN THE SURGEON EXAMINED THE DRIVER, IT WAS MISSING PART OF THE METAL BAND JUST UNDER THE THREADS. A NEW SCREW WAS PLACED WITH ANOTHER DRIVER. THERE WAS NO HARM TO THE PATIENT AND ANY DELAY WAS NEGLIGIBLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469396 ↗