Prosthesis, Rib Replacement
FDA adverse event reports and recall history for prosthesis, rib replacement (product code MDI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,051
- Deaths
- 15
- Injuries
- 906
- Malfunctions
- 127
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.
Recent recalls
- 2015-08-31TerminatedProcess control
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
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