K2M, Inc.
FDA adverse event reports naming K2M, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: K2M, INC..
- Total reports
- 2,563
- Deaths
- 0
- Injuries
- 1,153
- Malfunctions
- 1,401
Reports per year
2912
4313
4814
7315
12916
15217
1018
10719
35820
41321
42522
17523
16124
23625
17626
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 SystemNKB611
- Appliance, Fixation, Spinal Intervertebral BodyKWQ552
- Orthopedic Manual Surgical InstrumentLXH438
- Posterior Cervical Screw SystemNKG348
- Intervertebral Fusion Device With Bone Graft, LumbarMAX243
- Orthosis, Spinal Pedicle FixationMNI95
- Spinal Vertebral Body Replacement DeviceMQP75
- Appliance, Fixation, Spinal InterlaminalKWP43
- Orthosis, Spondylolisthesis Spinal FixationMNH40
- Intervertebral Fusion Device With Integrated Fixation, LumbarOVD40
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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