neon³ CT spinal stabilizationRecalls & reported problems across all models
Ulrich GmbH & Co. KG · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 18 models of neon³ CT spinal stabilization by Ulrich GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2016 and Dec 12, 2025 — classified as 27 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (16 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported neon³ CT spinal stabilization problems
Device problems
- Break16
- Fracture12
- Material Fragmentation4
- Migration4
- Material Deformation2
Patient problems
- Failure of Implant28
- Device Embedded In Tissue or Plaque4
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient4
- Implant Pain1
neon³ CT spinal stabilization models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- neon³ CT spinal stabilization CS 3906-40-30APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- neon³ CT spinal stabilization CS 3902-35-14Orthosis, cervical pedicle screw spinal fixation5 reports
- neon³ CT spinal stabilization CS 3902-35-16APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- neon³ CT spinal stabilization CS 3907-55-25Orthosis, cervical pedicle screw spinal fixation3 reports
- neon³ CT spinal stabilization CS 3901-01APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- neon³ CT spinal stabilization CS 3902-35-12APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- neon³ CT spinal stabilization CS 3906-40-34Orthosis, cervical pedicle screw spinal fixation2 reports
- neon³ CT spinal stabilization CS 3904-40-38Orthosis, cervical pedicle screw spinal fixation2 reports
- neon³ CT spinal stabilization CS 3902-35-18APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- neon³ CT spinal stabilization CS 3904-40-32Orthosis, cervical pedicle screw spinal fixation1 report
- neon³ CT spinal stabilization CS 3905-40-24Orthosis, cervical pedicle screw spinal fixation1 report
- neon³ CT spinal stabilization CS 3905-40-26Orthosis, cervical pedicle screw spinal fixation1 report
- neon³ CT spinal stabilization CS 3906-40-24APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- neon³ CT spinal stabilization CS 3906-40-26Orthosis, cervical pedicle screw spinal fixation1 report
- neon³ CT spinal stabilization CS 3906-40-32APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- neon³ CT spinal stabilization CS 3906-40-36APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- neon³ CT spinal stabilization CS 3907-45-35APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- neon³ CT spinal stabilization CS 3909-40-36Orthosis, cervical pedicle screw spinal fixation1 report
Recent neon³ CT spinal stabilization adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Fracture; Fracture
POSTOPERATIVE SCREW BREAKAGE AFTER APPROXIMATELY 10 MONTHS LED TO REVISION SURGERY.
Patient problems: Implant Pain
MAUDE report 23787104 ↗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 ↗InjuryNov 28, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OF POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18221286 ↗InjuryNov 28, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OF POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18219896 ↗InjuryNov 28, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OFF POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18219213 ↗InjuryNov 28, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OFF POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18218400 ↗InjuryJul 26, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OF POSTOPERATIVELY. PATIENT WILL BE REVISED IN WEEK 26.
Patient problems: Failure of Implant
MAUDE report 17401275 ↗InjuryJul 26, 2023Fracture; Fracture
POLYAXIAL HEAD OF SCREW BROKE OFF POSTOPERATIVELY. PATIENT WILL BE REVISED IN WEEK 26.
Patient problems: Failure of Implant
MAUDE report 17400039 ↗InjuryJun 25, 2021Break; Break
POST-OPERATIVE SCREW BREAKAGE. REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 12068821 ↗InjuryJun 25, 2021Break; Break
POST-OPERATIVE SCREW BREAKAGE. REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 12068816 ↗InjuryJun 25, 2021Break; Break
POST-OPERATIVE SCREW BREAKAGE. REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 12068815 ↗InjuryJun 25, 2021Break; Break
POST-OPERATIVE SCREW BREAKAGE. REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 12068814 ↗InjuryJun 4, 2021Material Deformation; Material Deformation
SCREW STRIPPED DURING IMPLANTATION AND WAS REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 11942649 ↗InjuryJun 4, 2021Material Deformation; Material Deformation
SCREW STRIPPED DURING IMPLANTATION AND WAS REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 11942648 ↗
Other Ulrich GmbH & Co. KG products
All Ulrich GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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