CD HORIZON® Spinal System NAV2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169347441), received between Oct 10, 2019 and Feb 28, 2023 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING MULTIPLE DRIVERS IN AN L3-L5 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT A LARGE DIAMETER SCREW WAS TRYING TO BE ADVANCED FURTHER INTO THE PEDICLE DURING A ROUTINE PLIF PROCEDURE. AFTER ENCOUNTERING RESISTANCE AND TRYING TO FORCE THE SCREW FURTHER, THE DISTAL TIP OF THE SCREW DRIVER BROKE. AS THE HCP TRIED MORE AND MORE DRIVERS, MORE SCREW DRIVERS WERE BEING BROKEN IN ATTEMPT TO MOVE THE IMPLANTED SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450701 ↗
• MalfunctionOct 27, 2022Break; Break

  THE PRE - OP DIAGNOSIS WAS FAILED HARDWARE (BROKEN ROD). THE PROCEDURE WAS AN EXTENSION OF FUSION TO T10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678609 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING FUSION. INTRA-OP, THE TIP OF THE DRIVER BROKE OFF INTO THE SCREW HEAD WHEN TRYING TO REMOVE THE SCREW. NO FRAGMENT OF THE BROKEN TIP REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176670 ↗

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