CD HORIZON® Spinal System 54840005530Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54840005530 MAS 5.5X30 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994589774), received between Mar 18, 2019 and Mar 18, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL STENOSIS, DEGENERATIVE DISC DISEASE AND SPONDYLOLISTHESIS L4-S1 AND UNDERWENT UNSPECIFIED PROCEDURE. POST-OP, SCREWS BROKE ROUGHLY 3-4 THREADS BELOW THE HEAD/TULIP. THE REMAINING SHANK OF SCREW WAS NOT RETRIEVED IN THE PATIENT. THE TIPS OF THE BILATERAL S1 SCREWS ARE REMAINING INSIDE THE PATIENT. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL THE BROKEN SCREWS. PATIENT SUFFERED WITH NON-UNION.
Patient problems: Failure of Implant
MAUDE report 8430930 ↗InjuryMar 18, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL STENOSIS, DEGENERATIVE DISC DISEASE AND SPONDYLOLISTHESIS L4-S1 AND UNDERWENT UNSPECIFIED PROCEDURE. POST-OP, SCREWS BROKE ROUGHLY 3-4 THREADS BELOW THE HEAD/TULIP. THE REMAINING SHANK OF SCREW WAS NOT RETRIEVED IN THE PATIENT. THE TIPS OF THE BILATERAL S1 SCREWS ARE REMAINING INSIDE THE PATIENT. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL THE BROKEN SCREWS. PATIENT SUFFERED WITH NON-UNION.
Patient problems: Failure of Implant
MAUDE report 8430929 ↗
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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