ATLANTIS Anterior Cervical Plate SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 94
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 1
We found 46 models of ATLANTIS Anterior Cervical Plate System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2017 and Jul 29, 2026 — classified as 52 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Break” (43 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
ATLANTIS Anterior Cervical Plate System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 23, 2021Terminated
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Z-1564-2021 · Root cause: Device Design · Recall details · FDA record ↗
Most reported ATLANTIS Anterior Cervical Plate System problems
Device problems
- Break43
- Migration or Expulsion of Device15
- Failure to Align9
- Adverse Event Without Identified Device or Use Problem5
- Migration5
- Device Slipped4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Naturally Worn3
Patient problems
- No Known Impact Or Consequence To Patient33
- No Clinical Signs, Symptoms or Conditions16
- Neck Pain13
- Pain11
- Failure of Implant10
- No Code Available6
- Weakness5
- Neuropathy4
ATLANTIS Anterior Cervical Plate System models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATLANTIS® Anterior Cervical Plate System 876-170APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 3120515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY12 reports
- ATLANTIS® Anterior Cervical Plate System 3120215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- ATLANTIS® Anterior Cervical Plate System 3120516APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY7 reports
- ATLANTIS® Anterior Cervical Plate System 3120313APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- ATLANTIS® Anterior Cervical Plate System 3120314APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- ATLANTIS® Anterior Cervical Plate System 3120517APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- ATLANTIS® Anterior Cervical Plate System 3120513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ATLANTIS® Anterior Cervical Plate System 3120514APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ATLANTIS® Anterior Cervical Plate System 3125517APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ATLANTIS® Anterior Cervical Plate System 3120416APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 6190062APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 6190045APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 3125515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 7200040APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 7200025APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 7200060APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 7200055APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ATLANTIS® Anterior Cervical Plate System 6190042Appliance, fixation, spinal intervertebral body2 reports
- ATLANTIS® Anterior Cervical Plate System 3120415APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190065APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190075APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190077APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190080APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190085APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190025APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190052APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 3120317APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 3120316APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 3120315APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 3125215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200085APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200080APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200150APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200042APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200037APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200023APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 7200075APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 876-715APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 876-815APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 876-614APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 876-615APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 976-155APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ATLANTIS® Anterior Cervical Plate System 6190040Appliance, fixation, spinal intervertebral body1 report
- ATLANTIS® Anterior Cervical Plate System 6190045Appliance, fixation, spinal intervertebral body1 report
- ATLANTIS® Anterior Cervical Plate System 7200025Appliance, fixation, spinal intervertebral body1 report
Recent ATLANTIS Anterior Cervical Plate System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50066810 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY C7-L1 INTERBODY FUSION PROCEDURE IN A PATIENT. PATIENT MEDICAL HISTORY: ANXIETY AND MIGRAINE HEADACHES DIAGNOSTICS: ACTION RESULT: ABNORMAL MILD TO MODERATE INCREASED TRACER ACTIVITY IS SEEN IN THE LOWER CERVICAL SPINE AT THE T7-L1 LEVEL. THIS IS SIMILAR TO THE PREVIOUS BONE SCAN. MOTION AT THIS LEVEL CANNOT BE EXCLUDED. MODERATE FOCAL ACTIVITY IS SEEN IN THE UPPER CERVICAL SPINE AT C3-C4 SUGGESTING INCREASED ARTHRITIC CHANGES AT THIS LEVEL IN COMPARISON TO THE PREVIOUS BONE SCAN. IT WAS REPORTED THAT THE SUBJECT DEVELOPED A CRACK AT THE INDEX FUSION SITE. C7-T1 PSEUDARTHROSIS WAS CONFIRMED INTRAOPERATIVELY. PATIENT WAS HOSPITALIZED FROM (B)(6) 2025. PATIENT UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2025 FOR REMOVAL OF IMPLANTS AT C4-T1 LEVELS AND ADDITIONAL DISCECTOMY / HEMICORTECTOMY AT C7-T1. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE ASSESSMENT, EVENT IS CAUSALLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. PATIENT WAS ADMINISTERED OPIATES OR NARCOTICS MEDICATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REG
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23921533 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT TO BE IMPLANTED WITH PLATES IN AN ACDF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT TWO PLATES BROKE WHEN COMPRESSING THE PLATE. IT WAS REPORTED THAT THERE WERE 2 BROKEN PLATES AND THEY CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PLATES WERE NEVER IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884595 ↗MalfunctionFeb 20, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED THAT LOCKING MECHANISM BROKE AND THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21419479 ↗MalfunctionFeb 12, 2025Break; Use of Device Problem; Break; Use of Device Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN A NTERIOR C5-C7 DISCECTOMIES AND FUSION SPINAL THERAPY FOR CERVICAL SPONDYLOSIS, STENOSIS, AND MYELOPATHY. LEVELS IMPLANTED WAS C5-7. IT WAS REPORTED THE SURGEON BENT IT SOME WITH HIS HANDS WERE NOT SUPPOSED TO BE BENT BUT THAT THEY DO HAVE SOME FLEX AND THEN PUT IT IN THE WOUND. UPON DOING THE FINAL TIGHTENING OF ALL 6 SELF-DRILLING FIXED ANGLE SCREWS THE PLATE DISTRACTED AND BROKE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362389 ↗MalfunctionFeb 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT TO BE IMPLANTED WITH PLATES IN AN ACDF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT TWO PLATES BROKE WHEN COMPRESSING THE PLATE. IT WAS REPORTED THAT THERE WERE 2 BROKEN PLATES AND THEY CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PLATES WERE NEVER IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342372 ↗MalfunctionSep 27, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C3-C6 SPINAL TH ERAPY FOR AN INDICATION OF C3-C6 DEGENERATIVE DISC DISEASE (DDD). IT WAS REPORTED THAT WHEN TURNING THE LOCK AT C3 SCREW, IT SHEARED OFF FROM THE PLATE AND WAS REMOVED AND REPLACE WITH LONGER PLATE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320341 ↗MalfunctionAug 26, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL SPINE SCREW PLATE FIXATION DUE TO ANTERIOR CERVICAL SPINE DOUBLE SEGMENT DEGENERATION.IT WAS REPORTED THAT PLATE BROKE. THE LOCKING RING ON THE ANTERIOR CERVICAL PLATE HAD FALLEN OFF. THIS EVENT OCCURRED BEFORE SURGERY, WHEN THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20063812 ↗MalfunctionMay 17, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY FOR STENOSIS. LEVELS IMPLANTED WAS C3-5. IT WAS REPORTED THAT THE MIDDLE AND BOTTOM SCREWS WERE IMPLANTED. WHEN ONE OF THE TOP SCREWS WAS BEING IMPLANTED, THE TOP OF THE PLATE BROKEN AND DISENGAGED FROM THE REST OF IT. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19340828 ↗MalfunctionMay 1, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). LEVELS IMPLANTED: C4-7. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS MYELOPATHY. IT WAS REPORTED THAT THE DEVICE LOCKING MECHANISM CAME OFF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE LOCKING MECHANISM BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219358 ↗InjuryNov 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH RADICULOPATHY SECONDARY TO A CRACK IN A PREVIOUSLY PLACED GRAFT AT C6/7 AND LOOSENING OF C7 SCREW. PLATE AND SCREW WERE BOTH REMOVED, AND CRACK IN THE GRAFT WAS CONFIRMED UPON INSPECTION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ADDITIONAL SURGERY WAS PERFORMED DUE TO LOOSE SCREWS AND EXPLANTED.
Patient problems: Neuropathy
MAUDE report 18215396 ↗InjuryNov 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH RADICULOPATHY SECONDARY TO A CRACK IN A PREVIOUSLY PLACED GRAFT AT C6/7 AND LOOSENING OF C7 SCREW. PLATE AND SCREW WERE BOTH REMOVED, AND CRACK IN THE GRAFT WAS CONFIRMED UPON INSPECTION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ADDITIONAL SURGERY WAS PERFORMED DUE TO LOOSE SCREWS AND EXPLANTED.
Patient problems: Neuropathy
MAUDE report 18215388 ↗InjuryNov 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH RADICULOPATHY SECONDARY TO A CRACK IN A PREVIOUSLY PLACED GRAFT AT C6/7 AND LOOSENING OF C7 SCREW. PLATE AND SCREW WERE BOTH REMOVED, AND CRACK IN THE GRAFT WAS CONFIRMED UPON INSPECTION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ADDITIONAL SURGERY WAS PERFORMED DUE TO LOOSE SCREWS AND EXPLANTED.
Patient problems: Neuropathy
MAUDE report 18215376 ↗InjuryNov 22, 2023Biocompatibility; Biocompatibility
INFORMATION WAS RECEIVED FROM A PATIENT, COMPETENT AUTHORITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT HAD A ATLANTIS C5-7 ANTERIOR FUSION PLATE PLACED FOR DISCS PROTRUDING ONTO SPINAL CORD. PATIENT DEVELOPED AUTOINFLAMMATORY DISORDER, ERYTHRODERMA SWELLING AND EDEMA IN TISSUES AND SKIN WHICH HAS NOT RESOLVED AND FOUND TO BE ALLERGIC TO TWO OF THE IMPLANT METALS - NICKEL AND TITANIUM. THERE WAS ALSO LOCAL SWELLING CAUSING DYSPHAGIA AND ABNORMAL SWELLING AND THICKENING OF TISSUE IN FRONT OF THE DEVICE BEHIND THE UPPER ESOPHAGUS ON CT SCAN. THERE WAS NO PREOP COUNSELLING ON METAL ALLERGY OR GUIDANCE ON PREOP METAL PATCH TESTING. THE PLATE WAS REMOVED. PLATE AND SCREWS WERE PLANNED FOR REMOVAL DUE EFFECTS OF SYSTEMIC METAL ALLERGY TO THE DEVICE COMPONENTS CAUSING LOCAL AND SYSTEMIC ALLERGIC REACTION WITH MULTIORGAN IMPAIRMENT. PREOP IMAGING SHOWED A BROKEN FIXATION SCREW IN THE C7 VERTEBRA AND PERIOPERATIVELY AFTER THE PLATE WAS REMOVED. THE FUSION WAS FOUND TO BE MOBILE - IE THE C5-7 FUSION HAD FAILED AND MY CERVICAL SPINE IS NOW UNSTABLE. THE BROKEN SCREW WILL HAVE CONTRIBUTED TO FUSION FAILURE. THE BROKEN SCREW HAD
Patient problems: Dysphagia/ Odynophagia; Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 18189162 ↗InjuryAug 9, 2023Break; Break
INFORMATION WAS RECEIVED FROM A (HEALTHCARE PROFESSIONAL, RISK MANAGER, REGULATORY BODY) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT THE SCREW BROKE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS HOSPITALIZED. THERE WERE NO PATIENTS SYMPTOMS OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486318 ↗
Other Medtronic Sofamor Danek, Inc. products
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- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
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- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page