AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB

[lasthope2.0]

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB

102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

Survival Until a Mechanical Malfunction:
Max - 14 years
Mean - 4 years
Median - 4 years

<= 1 year 35%
2-5 years 26%
6-10 years 35%
11-15 years 3%
16-20 years 0%


https://www.fda.gov/medical-devices/med ... data-files

[Thisworld]

Thanks

[Kodixx]

lasthope2.0, thanks also for sending this out. As with the Titan report, the number of failures seems really small given that hundreds of thousands of these are implanted over 10-20 years.

- Chuck

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB
102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

[Rodsmen]

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB

102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

Survival Until a Mechanical Malfunction:
Max - 14 years
Mean - 4 years
Median - 4 years

<= 1 year 35%
2-5 years 26%
6-10 years 35%
11-15 years 3%
16-20 years 0%


https://www.fda.gov/medical-devices/med ... data-files

Thank you so much for posting this. I have not yet succeeded in using the MAUDE DB. Is there a way to look for AMS 700CX cylinder failure reports?

[lasthope2.0]

lasthope2.0, thanks also for sending this out. As with the Titan report, the number of failures seems really small given that hundreds of thousands of these are implanted over 10-20 years.

- Chuck

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB
102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

I agree, Chuck, well stated. As always, I love your optimism. This is indeed a tiny number out of the 60,000 annual surgeries performed globally, with 30,000 in the US alone. These reports (though imperfect, delayed and under-reported) come in from all over the world.