CD Horizon® Spinal System 55740005545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55740005545 5.5/6 MAS 5.5X45 CC S · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 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 00613994995407), received between Dec 23, 2021 and Dec 30, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN P OSTERIOR LUMBAR INTERBODY FUSION (PLIF) SPINAL THERAPY. IT WAS REPORTED THE VERTEBRAL PEDICLE WAS FOUND TO BE AT RISK OF BREAKAGE WHILE USING A 5.5-DIAMETER TAP. THE SIZE WAS INCREASED TO A 6.5-DIAMETER BECAUSE THERE IS A CONCERN THAT THE PLANNED SIZE OF 5.5 SCREWS MAY LOOSEN. THE REPORTED PRODUCT WAS NOT USED ON THE PATIENT. A CUT-OUT OCCURRED IN THE PROBE BEFORE SCREW INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033067 ↗InjuryDec 23, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A SCREW BREAKAGE IN A REVISION SURGERY. THERE WAS A FRAGMENT LEFT IN THE PATIENT. THEY GAVE UP THE REMOVAL OF THE TIP OF THE SCREW SINCE IT WAS NEAR THE SPINAL CORD. AN ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF MEDTRONIC PRODUCT WAS UNKNOWN. PREOP DIAGNOSIS IS PJK.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13073958 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- 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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