Nuvasive, Inc.
FDA adverse event reports naming Nuvasive, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: NUVASIVE, INC..
- Total reports
- 1,478
- Deaths
- 14
- Injuries
- 320
- Malfunctions
- 1,096
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Thoracolumbosacral Pedicle Screw SystemNKB335
- Orthopedic Manual Surgical InstrumentLXH237
- Intervertebral Fusion Device With Bone Graft, LumbarMAX210
- Appliance, Fixation, Spinal Intervertebral BodyKWQ186
- Prosthesis, Intervertebral DiscMJO115
- Spinal Vertebral Body Replacement DeviceMQP82
- Appliance, Fixation, Spinal InterlaminalKWP49
- Intervertebral Fusion Device With Integrated Fixation, LumbarOVD28
- Orthosis, Spinal Pedicle FixationMNI27
- Neurosurgical Nerve LocatorPDQ25
Recent recalls
- 2023-02-03Open, ClassifiedSoftware design
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
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.
- 2022-12-20Open, ClassifiedDevice Design
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
- 2012-11-19TerminatedDevice Design
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
- 2012-11-19TerminatedDevice Design
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
The tulip portion of the screw assembly can disengage from the shank after implantation.
Monitor Nuvasive, Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.