CD HORIZON® Spinal System NAV2019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347502), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2017Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE: LUMBAR FUSION LEVELS OPERATED: T10-L3 IT WAS REPORTED THAT INTRA-OP, THE TIP OF THE DRIVER BROKE WHILE PLACING A SCREW IN THE LEFT LUMBAR THREE PEDICLE. NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6927950 ↗

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