August 2025 MPP Adverse Events

[LastHope]

Attached August 2025 MPP Adverse Events (Updated).

Total: 14 events

Genesis: 5 reported events
1 Erosion
1 Fracture
0 infection
3 Miscellaneous

Tactra: 9 reported events
1 Erosion
0 Fracture
0 Infection
8 Miscellaneous

Rigi10: 0 reported events

Note:
Miscellaneous - Included unknown/subjective reasons. See report for details.
MAUDE - Manufacturer and User Facility Device Experience

The FDA's 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.

[ElbowRoom]

Wow, a lot of dissatisfaction.

[LastHope]

Attached August 2025 MPP Adverse Events (Updated).

Total: 14 events

Genesis: 5 reported events
1 Erosion
1 Fracture
0 infection
3 Miscellaneous

Tactra: 9 reported events
1 Erosion
0 Fracture
0 Infection
8 Miscellaneous

Rigi10: 0 reported events

Note:
Miscellaneous - Included unknown/subjective reasons. See report for details.
MAUDE - Manufacturer and User Facility Device Experience

The FDA's 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.

Can't thank you enough for all your efforts.

Rigicon and surgeons should be obligated to report that of rigi10 as well.

Rigi10 having zero reports raises a huge suspcion of whether all failures in general are delivered.

You're welcome, TooYoung! Thank you for your passion. It's very exciting to learn about the failure points. Yes, it would be helpful to understand Rigi10’s strengths and weaknesses in these reports. It would also be good to know about explants due to infection salvage or as our surgeons affectionately call them, “placeholders” and “space savers”. This might help separate out the true failures while analyzing the monthly stats.

[RigiconDownUnder]

Can you guys share more details or DM on how to look up these stats on the FDA website? I'm interested in digging into the reports for Rigicon Infla10s and will be happy to help with these reports.

What's the data like for September for Rigicon Infla10 IPP models?