neon³ CT spinal stabilization CS 3902-35-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536084180), received between Jun 4, 2021 and Jun 4, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2021Material Deformation; Material Deformation

  SCREW STRIPPED DURING IMPLANTATION AND WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 11942649 ↗
• InjuryJun 4, 2021Material Deformation; Material Deformation

  SCREW STRIPPED DURING IMPLANTATION AND WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 11942648 ↗

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.