CD HORIZON® Spinal System NAV2002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169347540), received between Mar 31, 2020 and Mar 13, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K140454); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TAPS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RATCHET ON T HANDLES WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596643 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TAPS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RATCHET ON T HANDLES WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588065 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566689 ↗
• MalfunctionApr 29, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TAP STUCK IN PURPLE NAV TRACKER. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926138 ↗
• InjuryOct 5, 2023Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN FUSION SPINAL THERAPY FOR T9-T12 DECOMPRESSION. IT WAS REPORTED THAT THE PATIENT HAS MOTOR AND SENSORY ISSUES IN HIS LEG. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BLUE HANDLE BECAME DISENGAGED/MALFUNCTIONED FROM THE AWL TIP TAP CAUSING THE PATIENT A SPINAL CORD INJURY. THE SURGEON BELIEVES THAT THE SCRUB TECH NEVER CORRECTLY ATTACHED THE HANDLE TO THE AWL TIP TAP IN WHICH CAUSED THE INSTRUMENT TO SLIDE OFF THE HANDLE WHEN HE INTRODUCED TO THE SPINE. THERE IS NO ALLEGATION OF THE PURPLE NAV LOCK AS IT WAS SIMPLY ATTACHED TO THE AWL TIP TAP. SURGEON HAD 2 SCREWS IN BEFORE THIS INCIDENT USING THESE SAME INSTRUMENTS WITH NO ISSUE. AFTER THE INCIDENT THE SCRUB TECH THAT IS ALLEGING THE MALFUNCTION WAS GIVEN A BREAK AND WAS REPLACED BY ANOTHER SCRUB TECH FOR THE REMAINDER OF THE CASE. WE CONTINUED TO USE EXACTLY THE SAME INSTRUMENTS FOR 6 MORE SCREWS WITH NO ISSUE. THE REPORTED PATIENTS INJURY IS FROM THE 4.5 AWL TIP TAP WITH THE PURPLE NAV LOCK ATTACHED STRIKING THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Spinal Cord Injury; Unspecified Nervous System Problem

  MAUDE report 17875279 ↗
• MalfunctionMar 31, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM AND INSTRUMENT BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT THE DRIVER WAS DAMAGED AND IT WAS UNKNOWN HOW IT WAS DAMAGED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A PATIENT WAS NOT PRESENT WHEN THIS ISSUE WAS DISCOVERED SO THERE WAS NO PROCEDURE DELAY. THE DRIVER WAS STILL ABLE TO VERIFY. THE DAMAGE WAS TO THE SHAFT OF THE INSTRUMENT WHERE THE NAVLOCK CONNECTS TO THE INSTRUMENT AS THE DRIVER WOULD NOT PASS THROUGH ANY OF THE NAVLOCKS AT THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9902172 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140454. One submission often covers many models, so check the product and lot details in each record.

• Z-2363-2023 · Jul 12, 2023 · Open, Classified
  CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K