CD HORIZON SOLERA VOYAGER Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 60 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 411
- Deaths reported
- 1
- Injuries reported
- 112
- Recalls
- 0
We found 60 models of CD HORIZON SOLERA VOYAGER Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 411 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 29, 2026 — classified as 1 death, 112 injuries, 298 malfunctions.
The most frequently reported specific device problem is “Break” (136 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CD HORIZON SOLERA VOYAGER Spinal System problems
Device problems
- Break136
- Material Twisted/Bent96
- Loosening of Implant Not Related to Bone-Ingrowth33
- Device Dislodged or Dislocated31
- Material Deformation28
- Mechanical Problem16
- Mechanics Altered16
- Migration13
Patient problems
- No Clinical Signs, Symptoms or Conditions304
- No Known Impact Or Consequence To Patient39
- Pain21
- Device Embedded In Tissue or Plaque14
- Unspecified Infection11
- Unspecified Nervous System Problem7
- Failure of Implant5
- No Code Available5
CD HORIZON SOLERA VOYAGER Spinal System models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Appliance, fixation, spinal intervertebral body131 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System NAV6550005INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT62 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550002APPLIANCE, FIXATION, SPINAL INTERLAMINAL31 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6541104Appliance, fixation, spinal intervertebral body17 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016540APPLIANCE, FIXATION, SPINAL INTERLAMINAL12 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016545Orthopedic stereotaxic instrument11 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY10 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death9 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017545Orthopedic stereotaxic instrument9 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015540Thoracolumbosacral pedicle screw system7 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017545Orthopedic stereotaxic instrument6 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016540Appliance, fixation, spinal intervertebral body5 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016550Orthopedic stereotaxic instrument5 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850017545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT5 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT5 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017540INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT5 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014540DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)4 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016550Thoracolumbosacral pedicle screw system4 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750015540Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017535Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850046545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750046540Thoracolumbosacral pedicle screw system3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750046545Appliance, fixation, spinal intervertebral body3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850015545Appliance, fixation, spinal intervertebral body3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750014540Appliance, fixation, spinal intervertebral body3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017535INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6541101INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016550Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016535Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014530Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750015530APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750015545APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016530Orthopedic stereotaxic instrument2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850047550Appliance, fixation, spinal intervertebral body2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850017540INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015535APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015550APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016540Orthopedic stereotaxic instrument2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018540INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750018545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017550Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014535APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850047545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750045540Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750045545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750047535Thoracolumbosacral pedicle screw system1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750047540INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750047545Thoracolumbosacral pedicle screw system1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6551005INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850014545INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016555APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850018545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750014535Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015530INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017550Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017555APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018550INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018570Orthopedic stereotaxic instrument1 report
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 54850047545Thoracolumbosacral pedicle screw system1 report
Recent CD HORIZON SOLERA VOYAGER Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Mechanics Altered
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy. It was reported that the set screw had difficulty passing through the upper inner threads of the tulip, and the operation time was extended. Several set screws were attempted. The screw was explanted and replaced. There were no patient symptoms or complications have been reported as a result of this event. Additional information received from the manufacturer representative that the procedure involved was Transforaminal Lumbar Interbody Fusion to L4/5. Additional information received from the manufacturer representative that the delay occurred is less than 60 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928257 ↗MalfunctionSep 28, 2026Mechanical Problem
Information was received from multiple sources (Manufacturer Representative, User Facility, Other) regarding a Tab Extender used for thoracolumbar spine fixation therapy. It was reported that the tab extender was loose when checked with the cap attached. 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 50911075 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894115 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894092 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894029 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894024 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50894023 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50893989 ↗MalfunctionSep 25, 2026Corroded
Information was received from user facility via a manufacturer representative regarding a Extenders used for Spinal therapy. It was reported that rust was found on the sides of extender tab. Product was used numerous times. 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 50893983 ↗MalfunctionSep 11, 2026Material Twisted/Bent
Information was received from health care provider via manufacturing representative regarding a product identified during an event. It was reported that extender was bent. Preoperative diagnosis for this surgery L1, L3 burst fracture. No patient symptoms were reported. No further complications were reported/anticipated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734205 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50687226 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681908 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681902 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681860 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Information was received from the user facility via a manufacturer representative regarding a device used for spinal therapy. It was reported that the extenders were bent. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the instrument was used numerous times.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681856 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
- Catalyft LS Expandable Interbody System6 models · 3 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page