MDT Sofamor Danek Puerto Rico MFG
FDA adverse event reports naming MDT Sofamor Danek Puerto Rico MFG as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MDT SOFAMOR DANEK PUERTO RICO MFG.
- Total reports
- 6,786
- Deaths
- 14
- Injuries
- 3,023
- Malfunctions
- 3,742
Reports per year
4511
37712
60313
49914
61515
91816
61517
51418
45219
54820
42821
30122
24023
31424
30725
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Appliance, Fixation, Spinal InterlaminalKWP2,911
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW1,296
- Thoracolumbosacral Pedicle Screw SystemNKB1,195
- Intervertebral Fusion Device With Bone Graft, LumbarMAX483
- Stimulator, Electrical, Implantable, For IncontinenceEZW254
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY153
- Intervertebral Fusion Device With Integrated Fixation, CervicalOVE137
- Appliance, Fixation, Spinal Intervertebral BodyKWQ130
- Intestinal StimulatorLNQ51
- Pulse Generator, Permanent, ImplantableNVZ29
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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