Simplify Cervical Artificial DiscRecalls & reported problems across all models
Nuvasive, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Simplify Cervical Artificial Disc model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 1
We found 14 models of Simplify Cervical Artificial Disc by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2022 and Jul 14, 2026 — classified as 29 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Migration” (13 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Simplify Cervical Artificial Disc 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.
- Jun 20, 2022Open, Classified
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
Z-1453-2022 · Root cause: Labeling Change Control · names 10 of these models · Recall details · FDA record ↗
Most reported Simplify Cervical Artificial Disc problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Migration13
- Implant subsidence4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Loss of Osseointegration2
- Noise, Audible2
- Unintended System Motion2
- Flaked1
Patient problems
- Osteolysis15
- Pain15
- Neck Pain12
- Extraskeletal ossification8
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant4
- Bacterial Infection3
- Cyst(s)3
Simplify Cervical Artificial Disc models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall12 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall4 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall2 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall0 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall0 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall0 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 recall0 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc12 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc7 reports
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 report
- Simplify® Cervical Artificial DiscProsthesis, Intervertebral Disc1 report
Recent Simplify Cervical Artificial Disc adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Implant subsidence
Patient problems: Failure of Implant
MAUDE report 25813258 ↗MalfunctionApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SIMPLIFY DISC EXPLANT OCCURRED DUE TO OSTEOLYSIS AND RETURN OF ARM AND NECK PAIN. EXPLANT AND FUSION AT 5-6, 6-7 OCCURRED ON (B)(6) 2025.
Patient problems: Osteolysis
MAUDE report 25050236 ↗MalfunctionApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REMOVAL OF C3-C4 AND C4-C5 SIMPLIFY DISCS OCCURRED ON (B)(6) 2026. ORIGINAL DATE OF IMPLANTATION (B)(6) 2024. REVISION TO C4 CORPECTOMY AND FUSION. IT IS REPORTED THAT THE REASON FOR REMOVAL IS OSTEOLYSIS. C4-5 END PLATE LOOSE UPON REMOVAL. SPECIFICALLY, C-5 ENDPLATE, C4 ENDPLATE NOT LOOSE. C3-C4 ENDPLATES ARE NOT LOOSE AND SEEM WELL BONDED.
Patient problems: Osteolysis
MAUDE report 24876863 ↗MalfunctionApr 13, 2026Implant subsidence
REVISION OF 1 LEVEL FUSION AND 1 LEVEL CTDR TO 1 LEVEL FUSION. FUSION C5-6 CTDR C6-7. REMOVAL OF SIMPLIFY DISC DUE TO COLLAPSED VERTEBRAE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866063 ↗MalfunctionApr 8, 2026Implant subsidence
SIMPLIFY IMPLANT SUBSIDED FROM OSTEOLYSIS. EXPLANT TOOK PLACE ON (B)(6) 2026.
Patient problems: Osteolysis
MAUDE report 24815431 ↗MalfunctionMar 9, 2026Unintended System Motion
REMOVAL OF SIMPLIFY CTDR C5-C7 REVISION TO ANTERIOR CORPECTOMY A/P FUSION. IT WAS REPORTED THAT THE REASON FOR REMOVAL WAS A C6 PERIPROSTHETIC COMPRESSION FRACTURE. NO INFECTION DETECTED.
Patient problems: Failure of Implant
MAUDE report 24547998 ↗MalfunctionMar 9, 2026Unintended System Motion
FAILED 2 LEVEL CTDR REVISION TO CORPECTOMY. REMOVAL OF SIMPLIFY DISC DUE TO SUBSIDENCE, AND OSTEOLYSIS.
Patient problems: Failure of Implant
MAUDE report 24547613 ↗MalfunctionJan 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025 THERE WERE 2 DISCS EXPLANTED FROM THE CERVICAL SPINE. THE PATIENT HAD THESE PLACED THREE YEARS AGO BUT A COUPLE MONTHS AGO, FELL OFF OF A HORSE CAUSING INCREASED NECK PAIN. THIS IS THE REASON THEY DECIDED TO DO A FUSION AND REMOVE THE ARTIFICIAL DISCS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24133580 ↗MalfunctionJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE MAY BE AN INFECTION INVOLVING THE SIMPLIFY DISC IMPLANTED ON (B)(6) 2025. ANTICIPATE REMOVAL AND ACDF PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23949923 ↗MalfunctionAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SIMPLIFY IMPLANT HAD OSTEOLYSIS.
Patient problems: Osteolysis
MAUDE report 22902392 ↗MalfunctionAug 25, 2025Implant subsidence; Implant subsidence
SUBSIDENCE AT 4 WEEK FOLLOW UP. NOTED NO REPLACEMENT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883657 ↗InjuryApr 30, 2025Noise, Audible; Noise, Audible
ON (B)(6) 2023 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C4/5 AND C5/6 AS A RESULT OF TWO HERNIATED DISCS. POSTOPERATIVELY SHE HAS RECEIVED NO PAIN RELIEF AND IS EXPERIENCING NEW OCCIPITAL PAIN, ADDITIONALLY SHE HAS BEEN EXPERIENCING SQUEAKING AND CLICKING SOUNDS DURING ARTICULATION FOLLOWED BY PAIN. THE PAIN HAS STEADILY INCREASED AND AS A RESULT SHE IS UNABLE TO PERFORM WORK AND RECREATION ACTIVITIES. SURGEONS COMMENTED HIS RADIOGRAPHS SUGGESTED POSSIBLE HETEROTOPIC OSSIFICATION AND POSSIBLE NON-FUSION OF DISC END PLATES ALL THOUGH NO RADIOGRAPHS OR IMAGES HAVE BEEN PROVIDED AT THIS TIME NOR HAS A REVISION BEEN COMPLETED OR SCHEDULED.
Patient problems: Extraskeletal ossification; Neck Pain
MAUDE report 21937833 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C5/6 WITH NO REPORTED ISSUES. ON (B)(6), 2023 THE PATIENT REPORTEDLY RECEIVED A TWO LEVEL CTDR AT C4/5 AND C6/7 WITH NO REPORTED PROBLEMS BUT CONSIDERED OFF LABEL USAGE. ON (B)(6) 2025 FOLLOW UP THE SURGEON NOTED RECURRENT SYMPTOMS AND POSSIBLE OSTEOLYSIS BUT NO REVISION PLANNED AT THIS TIME.
Patient problems: Extraskeletal ossification; Inadequate Pain Relief; Osteolysis
MAUDE report 21636396 ↗InjuryMar 12, 2025Noise, Audible; Noise, Audible
ON (B)(6) 2025 A PATIENT UNDERWENT AN CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C6/7 DUE TO STENOSIS. AFTER THE PROCEDURE, THE PATIENT REPORTED THAT THE DISC MADE A NOISE WHEN MOVING THEIR HEAD/SPINE. ON (B)(6) 2025 A REVISION PROCEDURE TOOK PLACE WHEREIN THE ARTIFICIAL DISC AT C6/7 WAS REMOVED AND REPLACED WITH A NEW ONE. AFTER RE-IMPLANTATION OF THE REPLACEMENT PROSTHESIS NO NOISE OR CERVICAL DISCOMFORT WAS OBSERVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21585645 ↗MalfunctionFeb 10, 2025Migration; Migration
NEW OR UPDATED INFORMATION LISTED ON SECTION H10.
Patient problems: Failure of Implant
MAUDE report 21346185 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →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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