SimplifyRecalls & reported problems across all models
Nuvasive, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 13 models of Simplify by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2021 and Jul 16, 2026 — classified as 36 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Implant subsidence” (4 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 Simplify problems
Device problems
- Adverse Event Without Identified Device or Use Problem40
- Implant subsidence4
- Fracture2
- Loss of Osseointegration2
- Migration2
- Break1
- Crack1
- Material Fragmentation1
Patient problems
- Extraskeletal ossification20
- Osteolysis14
- Neck Pain8
- Pain7
- Stenosis7
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information3
- Limb Pain3
Simplify models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Simplify 2-4-CEProsthesis, intervertebral disc13 reports
- Simplify 5709424P2Prosthesis, intervertebral disc8 reports
- Simplify 5708914P2Prosthesis, intervertebral disc6 reports
- Simplify 1-4EV-CEProsthesis, intervertebral disc5 reports
- Simplify 2-5L-CEProsthesis, intervertebral disc5 reports
- Simplify 5709935P2Prosthesis, intervertebral disc3 reports
- Simplify 2-5-CEProsthesis, intervertebral disc3 reports
- Simplify 3-5L-CEProsthesis, intervertebral disc3 reports
- Simplify 1-5S-CEProsthesis, intervertebral disc2 reports
- Simplify 5709115P2Prosthesis, intervertebral disc1 report
- Simplify 2-4EV-CEProsthesis, intervertebral disc1 report
- Simplify 3-5-CEProsthesis, intervertebral disc1 report
- Simplify 3-6L-CEProsthesis, intervertebral disc1 report
Recent Simplify adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Implant subsidence
Patient problems: Osteolysis
MAUDE report 25846392 ↗MalfunctionJul 13, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Neck Pain
MAUDE report 25801070 ↗MalfunctionJun 23, 2026Implant subsidence
IT WAS REPORTED THAT THE ORIGINAL SIMPLIFY DISC IMPLANT SURGERY WAS DONE ON (B)(6) 2026. ON (B)(6) 2026 THE SURGEON EXPLANTED THE SIMPLIFY DISC DUE TO KYPHOSIS AND SUBSIDENCE AND PERFORMED AN ANTERIOR CERVICAL DISCECTOMY AND FUSION.
Patient problems: Insufficient Information
MAUDE report 25598199 ↗MalfunctionMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SIMPLIFY IMPLANT WAS EXPLANTED FROM THE PATIENT DUE TO OSTEOLYSIS.
Patient problems: Osteolysis
MAUDE report 25258020 ↗MalfunctionMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SIMPLIFY DISC EXPLANT WAS PLANNED FOR (B)(6) 2026 DUE TO OSTEOLYSIS.
Patient problems: Osteolysis
MAUDE report 25164319 ↗MalfunctionMay 6, 2026Adverse Event Without Identified Device or Use Problem
UNRESOLVED NECK PAIN. INITIAL SURGERY: 2025 WITH DR. (B)(6) AT (B)(6). REVISION: (B)(6) 2026 WITH DR (B)(6) AT (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25101017 ↗MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem
A SIMPLIFY DISC REMOVAL OCCURRED ON (B)(6) 2026. THE SURGEON REPORTED CONCERNS OF OSTEOLYSIS.
Patient problems: Osteolysis
MAUDE report 25058434 ↗MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem
A 60-YEAR-OLD FEMALE PATIENT HAD OSTEOLYSIS PRESENT SO CONVERTED TO 3 LEVEL FUSION WITH PLATE.
Patient problems: Osteolysis
MAUDE report 25058208 ↗MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem
A SIMPLIFY DISC REMOVAL DUE TO OSTEOLYSIS WAS REPORTED. CONVERTED TO FUSION.
Patient problems: Osteolysis
MAUDE report 25057555 ↗MalfunctionMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SIMPLIFY DISC WAS EXPLANTED DUE TO PAIN AND OSTEOLYSIS SEEN ON CT SCAN. EXPLANT DATE (B)(6) 2026.
Patient problems: Osteolysis
MAUDE report 24651539 ↗MalfunctionAug 26, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
IT WAS REPORTED THAT A SIMPLIFY IMPLANT WAS CHIPPED WHILE BEING REVISED INTRAOPERATIVELY, IT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898592 ↗MalfunctionAug 25, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A SIMPLIFY CAGE MIGRATED POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 22883179 ↗MalfunctionMar 18, 2025Implant subsidence; Implant subsidence
ON AN UNKNOWN DATE A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR). DURING THE 3 MONTH FOLLOW UP THE SURGEON NOTED POST OPERATIVE SUBSIDENCE AT THE INDEX LEVEL. NO REVISION IS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21638886 ↗MalfunctionMar 18, 2025Implant subsidence; Implant subsidence
ON (B)(6) 2024 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR). DURING THE 3 MONTH FOLLOW UP THE SURGEON NOTED POST OPERATIVE SUBSIDENCE AT THE INDEX LEVEL. NO REVISION IS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21638881 ↗InjuryFeb 18, 2025Unintended Movement; Unintended Movement
THIS COMPLAINT WAS IDENTIFIED DURING REVIEW OF THE SM1 SIMPLIFY DISC STUDY REPORT THE NOTED-ON (B)(6) 2016, A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT AT C4/5. ON (B)(6), 2024, THE PATIENT PRESENTED WITH NEW RECURRENT SYMPTOMS FIVE MONTHS AGO THAT HAVE PROGRESSIVELY WORSENED. THESE SYMPTOMS INCLUDE WEAKNESS, NECK STIFFNESS, AND PAIN, ALONG WITH BURNING SENSATIONS IN THE POSTERIOR NECK THAT EXTEND AROUND TO THE BASE OF THE NECK AND INTO THE CLAVICLE REGION. ADDITIONALLY, THE PATIENT EXPERIENCES NUMBNESS IN BOTH FOREARMS AFFECTING THE FOURTH AND FIFTH DIGITS AND HAS DEVELOPED SUBLUXATION AT THE INDEX LEVEL. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Burning Sensation; Muscle Weakness/Atrophy; Neck Pain; Numbness
MAUDE report 21405516 ↗
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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