CD HORIZON® Spinal System NAV1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169440265), received between Jun 7, 2018 and Aug 28, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SACROILIAC AND THORACOLUMBAR SPINAL SURGERY. THE PROCEDURE WAS A REMOVAL OF PRIOR L3-S1 POSTERIOR HARDWARE WITH EXTENSION AND FUSION FROM T10-PELVIS UTILIZING BALLAST CMAS SCREW SYSTEM AND SOLERA 5.5/6.0 SCREW SYSTEM. THE PREOP DIAGNOSIS WAS FAILED PRIOR FUSION WITH REVISION OF FAILED L5/S1 OLIF HARDWARE. SUPPLEMENTAL FIXATION WAS PROVIDED FROM T10-PELVIS ON THIS PARTICULAR SURGERY. IT WAS REPORTED THAT SCREWDRIVER WAS BROKEN DURING THE PROCEDURE. ISSUE OCCURED POST-INCISION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915611 ↗
• MalfunctionJul 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY REGARDING DEVICES USED FOR SPINAL FUSION. IT WAS REPORTED THAT THE BENDER, CURRETTE, REDUCER WERE BROKEN. THE TIP OF THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673357 ↗
• MalfunctionJul 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L2-ILLIUM POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT THE INSTRUMENT TIPS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505295 ↗
• MalfunctionMay 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING PSF REMOVAL OF SET SCREWS IN A PATIENT. IT WAS REPORTED THAT DRIVER TIPS BROKE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059168 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE SCREW DRIVER BROKE IN HALF. SCREW WAS ALREADY IN PATIENT. DRIVER BROKE ON THE LAST TURN OF THE SCREW SO THEIR WAS NO PROBLEM TO THE PATIENT. NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351956 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT RATCHETING HANDLE BROKE AND THE PROBE EXPERIENCED AN ISSUE WHERE THE NAV LOCK FRAME WOULD NOT SLIDE IN AND SLEEVE DRIVERS WAS BROKEN. THE TIP OF THE NAV AND MAS DRIVERS BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320298 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT RATCHETING HANDLE BROKE AND THE PROBE EXPERIENCED AN ISSUE WHERE THE NAV LOCK FRAME WOULD NOT SLIDE IN AND SLEEVE DRIVERS WAS BROKEN. THE TIP OF THE NAV AND MAS DRIVERS BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320285 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROFESSIONAL) REGARDING A NAV DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE DRIVER WAS BROKEN. THERE WAS NO PATIENT ISSUE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293761 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE ZEVO DRIVER WAS STRIPPED. THE INSERTER LOCKING TUBE WAS HAVING BROKEN THREAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289673 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE CANNULA WAS BROKEN AND THE TIP OF THE DRIVER WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236966 ↗
• MalfunctionJan 10, 2025Degraded; Degraded

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER HAVING LUMBAR FUSION TH ERAPY. IT WAS REPORTED THAT THE DRIVER WAS WORN OUT AND NOT HOLDING THE SCREWS VERY WELL. IT WAS NOT USED AFTER THAT CASE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124616 ↗
• MalfunctionNov 19, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE SNAPPED IN HALF.  THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20720733 ↗
• MalfunctionNov 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T10-PELVIS PSF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DRIVERS BROKE DURING SURGERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638877 ↗
• MalfunctionApr 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE END WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211811 ↗
• MalfunctionApr 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF REPORTED INSTRUMENT. IT WAS REPORTED THAT, TIP OF THE DRIVER BROKE OFF WITH SCREW INSERTION. TIP WAS RETRIEVED AND NO FURTHER DIFFICULTIES. THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134191 ↗
• MalfunctionJul 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. THE DRIVER WAS BROKEN IN SURGERY BUT THERE WAS NO PATIENTS INJURY OR COMPLICATIONS. IT WAS A SCOLIOSIS SURGERY. THE PRE OP DIAGNOSIS SCOLIOSIS. THE MECHANISM THAT HOLDS THE INSTRUMENT IS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105787 ↗
• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION DUE TO ADULT DEGENERATIVE SCOLIOSIS. INTRA-OP, THE DRIVES BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7576993 ↗
• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION DUE TO ADULT DEGENERATIVE SCOLIOSIS. INTRA-OP, THE DRIVES BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7576991 ↗