CD HORIZON® Spinal System 7578302Recalls & reported problems
Medtronic Sofamor Danek, Inc. · EXTENDER 7578302 5.5/6.0 EXTENDER BODY · Class 2
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This CD Horizon spinal system extender is a part of a pedicle screw system used in spinal surgery for scoliosis. Many of the 126 reports describe parts breaking or bending, often found during instrument checks, and most say the patient was not affected. The reports include no deaths and 9 injuries. Reports rose to 36 in the last 12 months from 24 in the previous 12. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 122
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00643169177055), received between Jan 10, 2017 and Aug 31, 2026 — classified as 9 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Break” (55 reports).
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
- Break55
- Mechanical Problem29
- Material Twisted/Bent14
- Mechanics Altered14
- Difficult to Remove9
- Disassembly5
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
Patient problems
- No Clinical Signs, Symptoms or Conditions78
- No Known Impact Or Consequence To Patient42
- No Consequences Or Impact To Patient5
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519416 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664227 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664212 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664188 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664170 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662923 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT DURING INSTRUMENT INSPECTION/CONTROL, EXTENDER BODY WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662610 ↗MalfunctionMay 5, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT SCREW COULD NOT BE FIXED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081277 ↗MalfunctionApr 2, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A EXTENDER HAVING POSTERIOR FIXA TION THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766480 ↗MalfunctionMar 30, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE SCREW WAS NOT FIXED. THE INSTRUMENT WAS USED FOR POSTERIOR FIXATION PROCEDURES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727798 ↗MalfunctionMar 5, 2026Mechanics Altered
ON 2025-DEC-26 MPXR 1379023 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE SCREW IS NOT FIXING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518428 ↗MalfunctionFeb 13, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCREW HEAD IS NOT SECURED. TYPE OF PROCEDURE USED WAS POSTERIOR FIXATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24339532 ↗MalfunctionFeb 13, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM THE REP THAT THE EXTENDER TIP CANNOT HOLD THE SCREW HEAD IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331066 ↗MalfunctionFeb 11, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT THE EXTENDER WON'T CONNECT WITH SCREW. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319730 ↗MalfunctionFeb 10, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR POSTER IOR FIXATION. IT WAS REPORTED THAT SCREW FIXING PART IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302735 ↗MalfunctionFeb 9, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE SCREW HEAD IS NOT SECURED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290176 ↗MalfunctionFeb 8, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE EXTENDER SCREW HEAD WAS NOT SECURED. THERE WAS NO PATIENT INVOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288615 ↗MalfunctionFeb 5, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING POSTERIOR FIXATION. IT WAS REPORTED THAT SCREW HEAD IS NOT SECURED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267906 ↗MalfunctionFeb 4, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE SCREW HEAD IS NOT SECURED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256830 ↗MalfunctionJan 21, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW IS NOT FIXING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24127907 ↗MalfunctionJan 20, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT, THE SCREW NOT FIXING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114956 ↗MalfunctionJan 20, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT, SCREW FIXING PART BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24113756 ↗MalfunctionJan 20, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT, SCREW WAS NOT FIXING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24113672 ↗MalfunctionJan 19, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EXTENDER USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT SCREW IS NOT FIXING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108634 ↗MalfunctionJan 15, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EXTENDER USED FOR POSTERIOR F IXATION THERAPY. IT WAS REPORTED THAT THE SCREW FIXING PART IN THE INSTRUMENT WAS BROKEN AND PRODUCT WAS USED BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24077721 ↗
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
- 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
- CD HORIZON® Spinal System 55840007550Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis14 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.
How reports and recalls are matched · Editorial policy · Report an error on this page