2025 October FDA Received TITAN Adverse Events

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Attached: 2025 October FDA Received TITAN Adverse Events

Total Events = 145
Mechanical = 101 (70%)

Summary of Titan mechanical adverse events:

N = 101
N with Event Date and Mfg Date = 81
Estimated Time to Event = (Event Date - Mfg Date – 1)
Assumption: 1 year of shelf life

Min – 5 months
Max – 17 yrs (Congratulations!! 49 year old from the US)
Mean – 6 yrs
Median – 5.5 yrs

Tubing (dominant failure domain)
• Failure modes named in the texts. Leak/leakage, fracture/break/breakage, tear, crack, fray, stretch-and-tear, complete separation, “connection came apart,” and “short” reservoir tubing.

• Locations explicitly called out. Near/above the pump; pump-to-cylinder runs (left or right side referenced in places); at the cylinder exit/base; next to the reservoir valve; pump–reservoir junction; reservoir tubing; “black tubing from cylinders.”

• Clinical/diagnostic presentation linked to tubing language. Device no longer inflates; system found empty by ultrasound/MRI; “loss of fluid” with free fluid reported in the scrotum; de-pressurized system causing the pump to feel mechanically locked; imaging or intra-op notes confirming broken/separated junctions.

• Explicit precipitating factors present in file. Patient traction (“yanking on the pump”) followed by break; tubing described as stretched before tearing; tubing length described as short at reservoir; separation at pump–reservoir connections noted intra-op.

• Operative actions described. Frequent full system exchange; multiple notes of non-returned product, limiting post-hoc analysis.

Cylinder
• Failure modes named. Cylinder aneurysm/bulge; cylinder leak not attributed to tubing; generalized “cylinder failure”; cylinders stuck inflated.

• Iatrogenic/handling events explicitly stated. Distal tip tear from deployment needles and suture traction during a virgin implant; distal puncture leak discovered after removal.

• Clinical/diagnostic presentation. Failure to inflate despite pump activation; stuck-inflation state; imaging sometimes nonspecific beyond an empty system; intra-op visualization of distal leak or aneurysm.

Pump
• Failure modes named. Pump malfunction (unspecified), pump fracture, housing “hole,” pump blocked, pump stiff/hard to compress, pump “stuck,” pump “losing fluid.”

• Systemic confounders present in file. Several pump complaints are tied to an empty/deflated system or upstream leak, with the pump then feeling nonfunctional or “locked.”

• Operative patterns. Pump exchanged alone or with cylinders while reservoir retained in some revisions; entire system exchanged in others.

Reservoir
• Issues explicitly mentioned. Unspecified reservoir malfunction; imaging reports of an apparently empty retropubic reservoir; a clinical impression of reservoir rupture later associated with a tubing fracture on that side; broken reservoir tubing with note that tubing length was short; partial separation of pump–reservoir connections (counted as tubing).

• Functional phenomena. Intermittent auto-inflation reported by the patient; device otherwise remains implanted in that account.

Other / Unlocalized in scope
• Unspecified device states. “Not working,” “stopped working,” “unknown malfunction,” or “mechanical failure” with no localization; device unable to inflate with no further detail; device not pumping properly; replacement of a prior device for unspecified reasons.

How failures present in the file
• Patient-level signals. Inability to inflate and absence of erection; sensation of free fluid; intermittent spontaneous inflation.

• Imaging/exam signals. Ultrasound/MRI showing an empty system or reservoir; CT used in at least one workup; clinical exam labeling a stuck or hard pump.

• Intra-op findings. Disconnected junctions at pump–reservoir; breaks along pump-to-cylinder runs; tears or cracks near junctions; distal cylinder wall defects or aneurysm; explicit confirmation of tubing separation or fracture near key interfaces.

Summary of Titan biological adverse events

Erosion / Extrusion
• Suspected extrusion with mechanical buckling: Implant on the left side folded onto itself and would not re-straighten; device explanted and replaced.

• Prior device removed for erosion with staged reimplantation: Initial inflatable system removed for erosion; later management used malleable components on one side and then the other.

• Reservoir extrusion from malposition: Reservoir functioning but in a poor anatomical position that led to extrusion; reservoir explanted and replaced.

• General device erosion: Device explanted and replaced for erosion without further anatomical detail.

• Erosion with intracorporal crossover: Device removed for erosion/crossover—suggesting breach of the intercavernous septum with component migration.

• Pending erosion (skin compromise risk): Device removed for impending erosion; separate case noted impending erosion through the scrotal skin.

• Unilateral cylinder erosion with staged management: One cylinder removed for erosion first; the remaining hardware removed and replaced later.

Infection
• Device infections leading to explantation: Multiple reports of explantation for infection, often with immediate conversion to malleable prostheses; in one case the device was not replaced at the same sitting.

• Early postoperative infection with intact mechanics: Primary implant later presented with infection despite normal mechanical function at explant; reservoir had been placed submuscularly and an antiseptic dip solution was used intraoperatively.

• Historical infection with delayed reimplantation: Device removed due to infection “a few years” prior, with subsequent malleable reimplantation at a later date.

• Literature context (from the abstract included): A multicenter, randomized non-inferiority trial reported that low-concentration chlorhexidine irrigation was not inferior to combined antibiotic irrigation for primary implantation with respect to infection prevention, with additional notes on ease of use and cost; both major manufacturers’ systems were represented.

Hematoma
• Postoperative hematoma requiring conversion: Device explanted and replaced with a malleable due to hematoma—indicates significant postoperative bleeding within the prosthesis field necessitating hardware exchange.

Pain + Discomfort
• Penile pain with device malfunction: Explantation attributed to penile pain associated with malfunction (no additional anatomical specifics provided).

• Progressive tubing discomfort: Long-term device revised when tubing became uncomfortable; narrative also acknowledges that mechanical wear, user factors, or malfunction can necessitate replacement over time.

Wound Dehiscence
• Corporotomy dehiscence with component bulging: The corporotomy opened and a cylinder was seen bulging outward; the cylinder was repositioned—consistent with fascial dehiscence at the corporal incision that threatened exposure/extrusion.

Notes from the manufacturer narratives
• Several explantations involved complete system replacement; others targeted specific components (cylinders, reservoir) depending on the biological issue (erosion, infection, hematoma) and intraoperative findings.

References:
-Manufacturer and User Facility Device Experience (MAUDE) Database https://www.accessdata.fda.gov/scripts/ ... search.CFM
-AI tools for parsing event summaries

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Attaching an executive summary of October 2025 FDA submissions for Coloplast Titan.