CD HORIZON® Spinal System NAV2023Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169347465), received between Jan 23, 2017 and Jun 6, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP IS WORN AND DOES NOT ALLOW GOOD CONTACT. 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 22157042 ↗
• MalfunctionMar 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE HAS 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 21569836 ↗
• MalfunctionNov 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER HAVING TLIF THERAPY. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER CHIPPED OFF INTO THE TULIP OF A SCREW. PRODUCT HAD BEEN USED MANY TIMES PREVIOUSLY. 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 20762443 ↗
• 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 15678611 ↗
• MalfunctionJan 23, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE: L4-5 POSTERIOR LUMBAR INTERBODY FUSION(PLIF) IT WAS REPORTED THAT ON (B)(6) 2016, INTRA-OP, TIP OF THE SCREWDRIVER BROKE AS THE BONE OF THE PATIENT WAS VERY HARD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269338 ↗

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