CD HORIZON® Spinal System 8672065Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 8672065 SEXTANT 65MM TI · 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 00721902180323), received between Dec 12, 2016 and Dec 12, 2016 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DATE OF REVISION SURGERY: (B)(6) 2016 (MONTH AND YEAR VALID) IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT SUFFERED WITH PAIN DUE TO THE SURGEON IMPLANTING RODS THAT WERE TOO LONG. THE RODS CAUSED DAMAGE TO HER ILIAC BONE. THE PATIENT STATED THAT THE CAGES WERE CRAMMED IN THERE. PATIENT UNDERWENT A REVISION SURGERY BUT DUE TO THE DAMAGED DONE BY THE FIRST SURGERY, PATIENT WAS NOT ABLE TO HAVE FUSION. PATIENT UNDERWENT REVISION SURGERY AND THE ROD WAS EXPLANTED. NEW RODS AND SCREWS WERE PLACED. NO HARDWARE FAILURE OR BREAKAGE WAS OBSERVED.
Patient problems: Injury; No Code Available; Pain
MAUDE report 6165671 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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