2025 September Coloplast Titan MAUDE Events

[lasthope2.0]

Apologies for the delay. I didn't receive my password reset notification and had to create an account. I will post the AMS700 and Malleable events in the next couple days.

Attached - 2025 September Coloplast Titan FDA Submitted MAUDE Events

What is MAUDE?
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.

From this reported limited sample:
Median time until a mechanical event without adjusting for shelf life - 6.5 years
Lowest - 5 months
Highest - 18 years (WOW! Congrats!)

Mechanical Events - 91
Total - 151

Mechanical Events summary:
### Cylinder events
-Cylinder breakage:
One cylinder broken and replaced.
-Cylinder leak: Device explanted/replaced due to leaking cylinder.
-Cylinder fraying:
Device explanted/replaced due to frayed cylinder.
-Cylinder tear:
Implant removed/replaced due to complete cylinder tear.
-Cylinder aneurysm:
Aneurysm on both narrow cylinders during implantation; inflation started after mild modeling.

### Tubing events
-Cylinder Tubing Breakage/Leak:
Device explanted/replaced due to breakage in distal/proximal cylinder tube, left/right cylinder tubing, cylinder-pump junction, or general cylinder tubing leak/tear.
-Pump Tubing/Connection Issues:
Device explanted/replaced due to breakage/hole/tear in pump tubing, pump-to-cylinder/reservoir tube, broken pump connection tube, or non-functional pump with cracked hose/fluid loss.
-Reservoir Tubing/Connection Issues:
Device explanted/replaced due to breakage/tear/leak in reservoir tubing, reservoir-cylinder connection, or incomplete tubing connection causing fluid loss/emptying.

### Pump Events
-None! Great job, Coloplast!

### Reservoir Events
- The reservoir was explanted and replaced due to auto inflation.

### Other events
-Auto-inflation (~80%) with possible uneven fill; won’t inflate (unused ~2 yrs)
-Hard to cycle
-Air in system
-Device age
-Fusiform mid-shaft aneurysm
-Titan Alpha explanted and replaced with a malleable (reason not stated)
-Deflated “accordioning” (shortening/buckling) and a base bulge on inflation, worsening over ~1 year

Biological Events Summary:
### Erosion/Extrusion/Migration/Herniation/Displacement
related
-Erosion/extrusion:
-Impending/pending distal erosion
-Erosion with infection and urethral perforation (purulence seen); unspecified erosion/extrusion.

-Migration/displacement:
-Reservoir migrated (out of retropubic space; into scrotum)
-Implant herniated/migrated out of corpora; device migrated from its space.

-Malposition/perforation: malposition with left corporal perforation.

### Infection
-Infection with erosion/urethral perforation; purulence noted
-Explant only (no replacement)
-Explant with immediate malleable (Genesis) replacement
-Explant with temporary Genesis to prevent fibrosis, then later hydraulic reimplantation
-Explant with later replacement (type unspecified)

### Other
-Explanted/replaced to upsize cylinder
-Reservoir reposition only; no parts replaced
-Explanted/replaced for broken tubing (gender-affirming case)
-Explanted/replaced for incorrect sizing
-S-shaped deformity managed without device exchange (literature)
-Explanted/replaced for short cylinders from 2017 implant causing leak
-Revision to reposition right cylinder
-Explanted/replaced with shorter device for sizing error
-Explanted/replaced with malleable due to hematoma
-Explanted/replaced per patient request for excess tubing and high-riding pump
-Reservoir tubing cut during hernia repair; device explanted/replaced
-Narrow RTE inner tray unsealed; used 18 cm device instead of planned 16 cm + RTEs
-Titan Touch 24 cm preconnect tubing too long; shortened intraoperatively
-Explanted/replaced for high-riding pump
-Explanted/replaced with single cylinder due to contralateral corporal scarring
-Preconnected 24 cm device required major tubing trims; surgeon prefers non-preconnected
-Revision to remove rear tip extenders for sizing error
-Urethra nicked during implant; procedure aborted

[ready2go]

so 151ipp's in a month, compared to 9 for a tactra malleable .
they need improvement, big time .
after i am dead and gone ,they will come out with some spectacular new device that never fails . hahaaa