neon³ CT spinal stabilization CS 3902-35-16Recalls & reported problems
Ulrich GmbH & Co. KG · Screw, Ø 3.5 mm, length 16 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04052536084203), received between Mar 24, 2020 and Mar 30, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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
Device problems
- Migration4
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2020Migration; Migration
POST OP X-RAYS REVEALED TWO SCREWS WERE BACKING OUT. A REVISION WAS SCHEDULED AND DONE ON (B)(6) 2020 AND OTHER ISSUES OCCURRED DURING THE REVISION. REPORT 2 OF 5.
Patient problems: Foreign Body In Patient
MAUDE report 9897264 ↗InjuryMar 30, 2020Migration; Migration
POST OP X-RAYS REVEALED TWO SCREWS WERE BACKING OUT. A REVISION WAS SCHEDULED AND DONE ON (B)(6) 2020 AND OTHER ISSUES OCCURRED DURING THE REVISION. REPORT 2 OF 5.
Patient problems: Foreign Body In Patient
MAUDE report 9897261 ↗InjuryMar 24, 2020Migration; Migration
POST OP X-RAYS REVEALED TWO SCREWS WERE BACKING OUT. A REVISION WAS SCHEDULED AND DONE ON (B)(6) 2020 AND OTHER ISSUES OCCURRED DURING THE REVISION. REPORT 1 OF 5.
Patient problems: Foreign Body In Patient
MAUDE report 9875673 ↗InjuryMar 24, 2020Migration; Migration
POST OP X-RAYS REVEALED TWO SCREWS WERE BACKING OUT. A REVISION WAS SCHEDULED AND DONE ON (B)(6) 2020 AND OTHER ISSUES OCCURRED DURING THE REVISION. REPORT 1 OF 5.
Patient problems: Foreign Body In Patient
MAUDE report 9875672 ↗
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
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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