neon³™ OCT spinal stabilization CS 3913-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04052536161454), received between Dec 3, 2018 and Feb 10, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K161032); 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 18, 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.

• InjuryFeb 10, 2021Break; Break

  AFTER THE IMPLANTATION OF THE TWO OC PLATES WITH RODS, THE RODS BROKE INSITU AFTER APPROX. 2 MONTHS. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 11311466 ↗
• InjuryFeb 10, 2021Break; Break

  AFTER THE IMPLANTATION OF THE TWO OC PLATES WITH RODS, THE RODS BROKE INSITU AFTER APPROX. 2 MONTHS. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 11311410 ↗
• InjuryFeb 10, 2021Break; Break

  AFTER THE IMPLANTATION OF THE TWO OC PLATES WITH RODS, THE RODS BROKE INSITU AFTER APPROX. 2 MONTHS. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 11311368 ↗
• InjuryFeb 10, 2021Break; Break

  AFTER THE IMPLANTATION OF THE TWO OC PLATES WITH RODS, THE RODS BROKE INSITU AFTER APPROX. 2 MONTHS. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 11311334 ↗
• InjuryDec 3, 2018Break; Break

  A PEDIATRIC PATIENT WHO HAD AN OCCIPITAL FIXATION SURGERY IN JULY HAD A REVISION SURGERY IN SEPTEMBER. HE CAME BACK TO THE HOSPITAL AND APPARENTLY THE SYSTEM WAS BROKEN. WHEN THE DOCTOR OPENED THE PATIENT IN THE REVISION SURGERY, HE SAW THAT THE RODS AND SCREWS WERE BROKEN, SO THEY REPLACED THE WHOLE SYSTEM AND ADDED MORE LEVELS.

  Patient problems: Failure of Implant

  MAUDE report 8126371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161032. One submission often covers many models, so check the product and lot details in each record.

• Z-1126-2019 · Mar 8, 2019 · Terminated
  ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.