neon³ CT spinal stabilization CS 3901-01Recalls & reported problems
Ulrich GmbH & Co. KG · Locking screw · Class 2 · Implant
All models of neon³ CT spinal stabilization (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536084159), received between Mar 29, 2019 and Jun 28, 2019 — classified as 1 injury, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
- Material Fragmentation1
Patient problems
- Failure of Implant2
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2019Break; Break
PIECE OF SCREW HEAD BROKE OFF INSIDE LOCKING SCREW. REPORT 2/2.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8745542 ↗InjuryMar 29, 2019Fracture; Material Fragmentation; Fracture; Material Fragmentation
DURING THE CASE, THE SCREW'S TULIP WAS SHEERED OFF DURING FINAL TIGHTENING. THE REP BELIEVES THIS MAY HAVE BEEN CAUSED BY CROSS THREADING THE LOCKING SCREW. THE SCREW WAS REMOVED AND REPLACED AND THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant
MAUDE report 8465475 ↗
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 · TerminatedUlrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
- Z-1126-2019 · Mar 8, 2019 · TerminatedULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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