CD HORIZON® Spinal System 54840047540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54840047540 4.75 ATS MAS 7.5X40 · 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
- 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 00643169438651), received between Jul 4, 2019 and Jul 4, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- Pain1
- Sleep Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2019Break; Break
IT WAS REPORTED PER PATIENT CALL THAT ON (B)(6) 2018, THE PATIENT UNDERWENT 2 LEVEL DISCECTOMY, 1 LEVEL LAMINECTOMY AND FUSION AT L3-S1. POST-OP, THE PATIENT EXPERIENCED PAIN IN LEG AND BACK; AND ALSO HAD DIFFICULTY SLEEPING. ALLEGEDLY, THE PATIENT'S VERTEBRAE DID NOT FUSE AS WELL. THE PATIENT UNDERWENT MRI ON (B)(6) 2018 DUE TO BACK PAIN. IMPRESSION: OVERALL SATISFACTORY APPEARING POSTSURGICAL CHANGES RELATED TO FUSION OF L3-4, L4-5, AND L5-S1; HOWEVER LEFT LATERAL RECESS NARROWING RESULTING IN LEFT S1 NERVE ROOT IMPINGEMENT AT THE L5-S1 LEVEL CANNOT BE RULED OUT. THE PATIENT UNDERWENT MYELOGRAM OF LUMBAR SPINE ON (B)(6) 2018 DUE TO BACK PAIN. IMPRESSION: 1. POSTSURGICAL CHANGES RELATED TO FUSION OF L3-4 THROUGH L5-S1. THERE IS PROBABLE FUSION OF THE RIGHT FACETS AT L3-4. THERE IS OTHERWISE NO INDICATION OF FUSION AS OF YET. THERE IS LOOSENING OF THE RIGHT S1 SCREW AND A FRACTURE OF THE LEFT S1 SCREW. 2. THE POSSIBLE LATERAL RECESS COMPROMISE AT L5-S1 NOTED ON THE PRIOR MRI APPEARS TO HAVE BEEN ARTIFACTUAL. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE HARDWARE WAS REMOVED AND REPLACED. PATIENT CONDITION IS NOW REPORTED TO BE HEALING.
Patient problems: Failure of Implant; Pain; Sleep Dysfunction
MAUDE report 8762236 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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