neon³™ OCT spinal stabilization CS 3913-08Recalls & reported problems
Ulrich GmbH & Co. KG · Occipital plate, midline, 47 mm, for rod, Ø 4.0 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04052536161485), received between Dec 26, 2018 and Mar 30, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
1 other recall cover devices cleared under the same FDA submission (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
- Break2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2020Break; Break
A REVISION WAS DONE (B)(6) AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION THEY DISCOVERED THAT A TULIP HEAD ON THE OC PLATE HAD BROKEN OFF. REPORT 3 OF 5.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9897260 ↗InjuryMar 30, 2020Break; Break
A REVISION WAS DONE 6 MARCH AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION THEY DISCOVERED THAT A TULIP HEAD ON THE OC PLATE HAD BROKEN OFF.. REPORT 3 OF 5.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9897259 ↗InjuryDec 26, 2018Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
DURING SURGERY, ONE OF THE SLIDING TULIPS ON THE OC PLATE SLID OFF OF THE PLATE. THE SURGEON REMOVED AND REPLACED THE ENTIRE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 8197760 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161032. One submission often covers many models, so check the product and lot details in each record.
- 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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