Nuvasive, Inc.
7475 Lusk Blvd, SAN DIEGO, CA, US
Registered product codes
60 product codes
Recent MDR events
2,006 on file
- Simplify® Cervical Artificial DiscJul 31, 2026Injury2031966-2026-00096
- Simplify® Cervical Artificial DiscJul 31, 2026Injury2031966-2026-00097
- ReLineJul 27, 2026Malfunction2031966-2026-00091
- ReLineJul 27, 2026Malfunction2031966-2026-00092
- ReLineJul 27, 2026Malfunction2031966-2026-00093
- SIMPLIFY® CERVICAL ARTIFICIAL DISCJul 21, 2026Malfunction2031966-2026-00090
- SIMPLIFYJul 16, 2026Malfunction2031966-2026-00089
- SIMPLIFY® CERVICAL ARTIFICIAL DISCJul 14, 2026Malfunction2031966-2026-00084
- SIMPLIFYJul 13, 2026Malfunction2031966-2026-00088
- RELINEJul 1, 2026Malfunction2031966-2026-00087
Recalls
36 on file
- Open, ClassifiedFeb 3, 2023
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
View FDA record ↗ - Open, ClassifiedDec 20, 2022
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗ - TerminatedNov 19, 2012
The tulip portion of the screw assembly can disengage from the shank after implantation.
View FDA record ↗
Compliance history
Matched by FEI 3002980729.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.