neon³ CT spinal stabilization CS 3907-45-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536084555), received between Apr 19, 2017 and Apr 19, 2017 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K150650, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2017Break; Break

  SURGEON WAS REDUCING ROD AND INSERTING THE LOCKING SCREW WHEN THE TOP OF THE TULIP ON THE PEDICLE SCREW ON ONE SIDE BROKE OFF. THIS CAUSED A DELAY IN SURGERY. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6505011 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150650, K161032. One submission often covers many models, so check the product and lot details in each record.

• Z-1350-2020 · Dec 31, 2019 · Terminated
  Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
• 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.