Bone Cement, Posterior Screw Augmentation
FDA adverse event reports and recall history for bone cement, posterior screw augmentation (product code PML), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 301
- Deaths
- 8
- Injuries
- 174
- Malfunctions
- 119
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-01-10Open, ClassifiedOther
VADER pedicle system, torque wrench, Catalog Number 42-702
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
- 2024-01-10Open, ClassifiedOther
VADER pedicle system, torque wrench, Catalog Number 42-703
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
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