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neon³ CT spinal stabilization CS 3906-40-26Recalls & reported problems

Ulrich GmbH & Co. KG · Screw, cannulated, favored angle medial, Ø 4.0 mm, length 26 mm · Class 2 · Implant

All models of neon³ CT spinal stabilization (18)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536084470), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryMar 29, 2019Fracture; Fracture

    USING X-RAY EVALUATION, THE SURGEON DECIDED TO MANUALLY SCREW THE SCREW A LITTLE DEEPER INTO THE BONE. WHEN TRYING TO SCREW THE SCREW IN FURTHER, THE SCREW BROKE BELOW THE SCREW HEAD. PART OF THE SCREW SHAFT REMAINED IN THE BONE. THE SCREW TYPE IN QUESTION IS A SELF-TAPPING SCREW WHICH MUST BE PRE-DRILLED DURING PREPARATION ACCORDING TO THE SURGICAL TECHNIQUE. OPTIONALLY, IT IS ALSO POSSIBLE TO USE A TAP FOR SCLEROTIC BONE. THE FOLLOWING FINDINGS WERE OBTAINED DURING THE INITIAL USER CONSULTATION: THE HOLE FOR THE SCREW WAS PRE-DRILLED TO A DEPTH OF ONLY 12MM. THE SCREW LENGTH IS 26MM. THE BONE QUALITY WAS DESCRIBED BY THE USER AS VERY HARD DUE TO DEGENERATION AND SCLEROTIC ATTACHMENTS.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8465479 ↗

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.

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page