CD HORIZON® Fenestrated Screw Set 55851025545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS SAS 55851025545 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 00763000143756), received between Aug 10, 2022 and Aug 10, 2022 — 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
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS TRAUMA STABILIZATION FOR T12 BURST FRACTURE. LEVELS IMPLANTED: T11-L1 IT WAS REPORTED THAT THE SCREWS SHANKS BROKE UNDER TULIP. 1-MONTH POST-OPERATIVE, THE SURGEON REPORTED THAT 1 SCREW HAD BROKEN, AT 3 MONTHS FOLLOW UP 2 SCREWS HAD BROKEN. REMOVAL OF SCREWS AND FUSION IS SCHEDULED TO HAPPEN IN THE NEXT 2 WEEKS DUE TO BROKEN SCREWS AND LOSS OF CORRECTION. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY 2 SCREWS BROKE AND IT IS UNKNOWN WHICH SCREWS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15202385 ↗
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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