Calix Spinal Implant System X034-0015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M697X03400151), received between Oct 5, 2018 and Jul 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816951 ↗
• MalfunctionMar 26, 2026Break

  THE MANUFACTURER WAS CONTACTED ON 03/02/2026 TO REPORT AN ISSUE WITH TWO SYSTEM INSERTERS. IT WAS REPORTED THAT THE DISTAL THREADED TIPS OF THE INNER SHAFTS OF THE INSERTERS WERE FRACTURED FROM THE INSTRUMENTS WHILE THEY WERE BEING USED TO PLACE IMPLANTS DURING A L3-S1 TLIF. THIS INCIDENT OCCURRED WITH TWO DIFFERENT INSERTERS ON TWO SEPARATE IMPLANTS. THE FRACTURED TIPS OF THE INSERTERS WERE NOT RECOVERABLE AS THEY REMAINED EMBEDDED IN THE IMPLANTS, WHICH WERE SUCCESSFULLY IMPLANTED WITH THE INSERTERS DESPITE THE REPORTED ISSUES. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENTS, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 03/12/2026. REPORT 2 OF 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698820 ↗
• MalfunctionMar 26, 2026Break

  THE MANUFACTURER WAS CONTACTED ON 03/02/2026 TO REPORT AN ISSUE WITH TWO SYSTEM INSERTERS. IT WAS REPORTED THAT THE DISTAL THREADED TIPS OF THE INNER SHAFTS OF THE INSERTERS WERE FRACTURED FROM THE INSTRUMENTS WHILE THEY WERE BEING USED TO PLACE IMPLANTS DURING A L3-S1 TLIF. THIS INCIDENT OCCURRED WITH TWO DIFFERENT INSERTERS ON TWO SEPARATE IMPLANTS. THE FRACTURED TIPS OF THE INSERTERS WERE NOT RECOVERABLE AS THEY REMAINED EMBEDDED IN THE IMPLANTS, WHICH WERE SUCCESSFULLY IMPLANTED WITH THE INSERTERS DESPITE THE REPORTED ISSUES. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENTS, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 03/12/2026. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698161 ↗
• MalfunctionFeb 3, 2026Break

  THE MANUFACTURER WAS MADE AWARE OF A SYSTEM COMPLAINT ON 01/09/2026 IN WHICH IT WAS REPORTED THAT THE DISTAL TIP OF AN INSERTER SHAFT BROKE FROM THE DEVICE AS IT WAS BEING USED TO PREP AN IMPLANT FOR A LUMBAR FUSION. THE COMPLAINANT STATED THAT, "THE SURGICAL TECH WENT TO SCREW THE INSERTER INTO THE IMPLANT ON THE BACK TABLE AND THE TIP BROKE OFF IN THE IMPLANT, THE TIP WAS UNSCREWED OUT OF THE IMPLANT AND A NEW INSERTER INSTALLED AND IMPLANT WAS LOADED ONTO NEW INSERTER AND IMPLANTED WITH NO ISSUE. WE REMOVED THE OLD INSERTER SHAFT AND TIP THAT BROKE OFF AND ITS BEING SENT BACK". THERE WERE NO REPORTED PATIENT COMPLICATIONS OR DELAYS IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251804 ↗
• MalfunctionAug 1, 2022Solder Joint Fracture; Solder Joint Fracture

  THE MANUFACTURER RECEIVED NOTIFICATION ON 7/06/2022 OF AN IMPLANT INSERTER THAT MALFUNCTIONED DURING A PROCEDURE. IT WAS REPORTED THAT WHILE IMPACTING THE INSERTER WITH A MALLET, A HANDLE T-PIN FELL OFF THE IMPLANT INSERTER. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. THE COMPLAINT INSTRUMENT WAS RECEIVED ON 7/07/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138474 ↗
• MalfunctionSep 27, 2021Solder Joint Fracture; Solder Joint Fracture

  THE COMPANY RECEIVED NOTIFICATION ON 8/31/2021 OF AN IMPLANT INSERTER THAT MALFUNCTIONED DURING A PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT WHILE IMPACTING THE INSERTER WITH A MALLET, THE PHYSICIAN INADVERTENTLY IMPACTED THE INSERTER T-HANDLE. THE IMPACT TO THE INSERTER T-HANDLE RESULTED IN AN INSTRUMENT MALFUNCTION. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537470 ↗
• MalfunctionNov 12, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 REGARDING AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE THREADED DISTAL TIP OF A SYSTEM INSERTER FRACTURED INSIDE OF AN IMPLANT WHEN BEING PLACED. THE IMPLANT WITH THE FRACTURED DISTAL TIP OF THE INSERTER WAS REMOVED AND REPLACED WITH ANOTHER IMPLANT. THERE WAS AN ALTERNATE INSERTER AVAILABLE, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS INSTRUMENT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829704 ↗
• MalfunctionOct 5, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT TWO INSERTERS FAILED IN THE FIELD. THE MALFUNCTION WAS DISCOVERED PRIOR TO IMPLANTATION DURING A SURGERY. AN ALTERNATE INSTRUMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7940494 ↗