CD HORIZON® Fenestrated Screw Set 55751025545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS SAS 55751025545 STER CCM 5.5 X 45 · Class 2 · Implant
All models of CD HORIZON Fenestrated Screw Set (27)
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 00763000150594), received between Jul 31, 2025 and Jul 31, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Back pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBRAL BODY REDUCTION FOR L1 BURST FRACTURE (T11 TO L1 FIXATION) IT WAS REPORTED THAT THE SCREWS WERE BROKEN. THE BROKEN SCREW HEAD CAME IN CONTACT WITH THE SKIN, AND IT CAUSED BACK PAIN. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. DURING THE INITIAL SURGERY, 11 WAS FIXATED TO L1. VF WAS USED TO PERCUTANEOUSLY REDUCE THE VERTEBRAL BODY. THE PATIENT WAS INSTRUCTED TO WEAR A CORSET AND REST FOR 3 MONTHS AFTER THE SURGERY. THE STATUS OF COMPLIANCE IS UNKNOWN. THE PATIENT COMPLAINED OF BACK PAIN STARTING FROM THE 4TH MONTH; UPON IMAGE EVALUATION, A CORRECTION LOSS WAS OBSERVED, AND A SHAFT FRACTURE WAS CONFIRMED IN THE RIGHT SIDE OF THE HEAD SCREW AND THE LEFT SIDE OF THE CAUDAL SCREW. IT WAS CONFIRMED THAT THE SHAFT WAS BROKEN ON THE RIGHT SIDE OF THE HEAD SCREW AND THE LEFT SIDE OF THE CAUDAL SCREW. THE SHAFT AND SCREW HEAD WERE ALSO REMOVED USING THE REMOVABLE KIT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Back pain
MAUDE report 22673434 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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