2025 September MPP MAUDE Events

[lasthope2.0]

Attached - 2025 September MPP FDA Submitted MAUDE Events

MPP Event Counts:
Tactra - 9
Genesis - 5
Spectra - 1
Total - 15

Tactra:
Infection - 0
Erosion - 0
Fracture - 0
Deformity - 2

Genesis:
Infection + Erosion - 1
Fracture - 0
Deformity - 0

MAUDE - Manufacturer and User Facility Device Experience
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

[easymoney]

Does Rigicon not submit their failures?

[lasthope2.0]

Does Rigicon not submit their failures?

Not so much.
I've only seen one significant event for Rigi10 so far. This was submitted in July for urethral erosion.

Event Description (Rigi10 - Report Number MW5173423):
It was reported that patient had an explant of their rigicon device. This was due to urethral erosion.

https://www.accessdata.fda.gov/scripts/ ... uence_no=1