Simplify® Cervical Artificial Disc (REF SM-6)Recalls & reported problems
Nuvasive, Inc. · Simplify® Cervical Artificial Disc Size SM, Height 6 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843285100047), received between Mar 9, 2026 and Mar 9, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended System Motion” (2 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Unintended System Motion2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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 · each recall links to the FDA recall notice
- 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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