CD HORIZON® Spinal System 54840004540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54840004540 MAS 4.5X40 CC · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994589576), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K091974); 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
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2021Break; Break
INFORMATION WAS RECEIVED FROM A CONSUMER VIA A HEALTHCARE PROFESSIONAL (HCP)/ MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPINAL PRODUCT IN A LAMINECTOMY/FUSION SURGERY AT L4-5. IT WAS REPORTED THAT ONE OF THE SCREWS ENDED UP SNAPPING AND THE PATIENT HAD TO HAVE A SECOND SURGERY ON (B)(6) 2021 WHERE THEY REMOVED THE PREVIOUS HARDWARE AND REPLACED IT WITH RODS, MAS SCREWS, SET SCREWS, AND BONE SCREWS (MDT PRODUCTS). THE DATE OF INITIAL SURGERY WAS (B)(6) 2020. AS A RESULT OF THE SECOND SURGERY, THE PATIENT DEVELOPED A HERNIA AND HAD TO BE HOSPITALIZED ON FOR A HERNIA REPAIR ON (B)(6) 2021. AS A RESULT OF THE HERNIA REPAIR SURGERY, THE PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. THE PATIENT IS IN PAIN. THE DATE OF IMPLANT WAS (B)(6) 2020 AND DATE OF EXPLANT WAS (B)(6) 2021. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: Pain
MAUDE report 12818108 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.
- Z-2876-2011 · Jun 28, 2011 · TerminatedCD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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