Clydesdale Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 25 models of Clydesdale Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 24, 2026 — classified as 9 injuries, 76 malfunctions.
The most frequently reported specific device problem is “Break” (66 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 Clydesdale Spinal System problems
Device problems
- Break66
- Crack5
- Migration5
- Adverse Event Without Identified Device or Use Problem4
- Mechanics Altered2
- Detachment of Device or Device Component1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Known Impact Or Consequence To Patient26
- Device Embedded In Tissue or Plaque4
- Pain4
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Intraoperative Pain1
- Neurological Deficit/Dysfunction1
Clydesdale Spinal System models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Clydesdale™ Spinal System 2942001Intervertebral fusion device with bone graft, lumbar24 reports
- Clydesdale™ Spinal System 2968250Intervertebral fusion device with bone graft, lumbar10 reports
- Clydesdale™ Spinal System 2968050Intervertebral fusion device with bone graft, lumbar7 reports
- Clydesdale™ Spinal System 2968255Intervertebral fusion device with bone graft, lumbar6 reports
- Clydesdale™ Spinal System 2968045Intervertebral fusion device with bone graft, lumbar5 reports
- Clydesdale™ Spinal System 2968245Intervertebral fusion device with bone graft, lumbar4 reports
- Clydesdale™ Spinal System 2922255Intervertebral fusion device with bone graft, lumbar3 reports
- Clydesdale™ Spinal System 2922055Intervertebral fusion device with bone graft, lumbar3 reports
- Clydesdale™ Spinal System 2968040Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System 2968845Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System X0909604Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System 2922450Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System 2926845Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System 2922245Intervertebral fusion device with bone graft, lumbar2 reports
- Clydesdale™ Spinal System 2968240Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2968055Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2968855Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2968650Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2968455Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2922660Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2922460Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2922445Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2926250Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2922250Intervertebral fusion device with bone graft, lumbar1 report
- Clydesdale™ Spinal System 2922045Intervertebral fusion device with bone graft, lumbar1 report
Recent Clydesdale 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 24, 2026Break
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Oblique Lateral Interbody Fusion due to Herniated Disc Disease. It was reported that during the procedure while inserting, cages broke. There was no patient symptom reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881197 ↗MalfunctionSep 24, 2026Break
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Oblique Lateral Interbody Fusion due to Herniated Disc Disease. It was reported that during the procedure while inserting, cages broke. There was no patient symptom reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881099 ↗MalfunctionAug 5, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139607 ↗MalfunctionJun 9, 2026Break
ON (B)(6) 2025 MPXR 1351860 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LUMBAR INTERBODY FUSION (OLIF) FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN THE FUSION DEVICE WAS ALMOST IN POSITION DURING IMPLANTATION, THE TIP END CONNECTED TO THE FUSION DEVICE BROKE. THE BROKEN PART WAS REMOVED, BUT THE PORTION ALREADY IMPLANTED COULD NOT BE REMOVED. SINCE IT WAS RELATIVELY INTACT, IT WAS LEFT INSIDE THE PATIENT TO SERVE AS STRUCTURAL SUPPORT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25446288 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS DISASSEMBLED AND UNUSABLE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146109 ↗MalfunctionMar 31, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF). IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740650 ↗MalfunctionMar 30, 2026Break
INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF). IT WAS REPORTED THAT THE INSERTER 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 24729743 ↗MalfunctionMar 13, 2026Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592737 ↗MalfunctionMar 13, 2026Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587838 ↗MalfunctionMar 11, 2026Break
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSERTER BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574110 ↗MalfunctionMar 10, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN. IT WAS USED FOR DIRECT LATERAL INTERBODY FUSION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557966 ↗MalfunctionMar 10, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INNER SHAFT THREADS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557824 ↗MalfunctionFeb 6, 2026Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277443 ↗MalfunctionJan 21, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION. IT WAS REPORTED THAT THE THREAD WIRE IS BROKEN AND UNUSABLE. IT WAS AN UNDESIRED DAMAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. IT WAS AN UNDESIRED DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24128042 ↗MalfunctionDec 8, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741335 ↗
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
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- 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
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.
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