neon³ CT spinal stabilization CS 3902-35-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04052536084197), received between Jun 21, 2018 and Jun 5, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Fracture; Fracture

  A PEDICLE SCREW BROKE DURING SURGERY; PART OF IT HAD TO BE LEFT IN THE PATIENT. THE RESULT WAS A DELAY IN THE OPERATING TIME.

  Patient problems: Failure of Implant

  MAUDE report 22154028 ↗
• MalfunctionMay 14, 2025Fracture; Fracture

  "BREAKAGE OF A PEDICLE-SCREW DURING SURGERY. THIS RESULTS IN A DELAY IN THE OPERATION TIME. ACCORDING TO REPORTING PERSON: "WE ARE VERY SORRY TO INFORM YOU THAT THE ITEM BROKE DURING THE SURGERY AND PART OF IT HAS BEEN LEFT INSIDE THE PATIENT.""

  Patient problems: Failure of Implant

  MAUDE report 22018886 ↗
• 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 8126367 ↗
• InjurySep 24, 2018Break; Break

  LATERAL MASS SCREW WAS INSERTED AS PER STANDARD TECHNIQUE (PRE-DRILLING). AS THE SCREW WAS DRIVEN INTO THE BONE, THE SCREW SHANK BROKE AWAY FROM THE HEAD OF THE SCREW. THE SCREW SHANK REMAINED IN THE PATIENT. THE REMAINS OF THE SCREW WERE RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7904266 ↗
• InjuryJun 21, 2018Break; Break

  TULIP HEAD OF SCREW BROKE DURING IMPLANTATION. THE SCREW WAS REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626972 ↗

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.