Simplify 5709115P2Recalls & reported problems
Nuvasive, Inc. · Simplify Disc Size 1, Ht 5 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195377105424), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
1 other recall cover devices cleared under the same FDA submission (P200022); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Burning Sensation1
- Muscle Weakness/Atrophy1
- Neck Pain1
- Numbness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P200022. One submission often covers many models, so check the product and lot details in each record.
- Z-1453-2022 · Jun 20, 2022 · Open, ClassifiedDescription/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht
Other Prosthesis, intervertebral disc devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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