2026 March Titan MAUDE Adverse Event Report Summary
Posted: Mon May 04, 2026 7:15 pm
20 point summary of 129 event descriptions:
20-Point Summary
**UPDATE**
Of the mechanically malfunctioned devices, only 55 of them had documented implant and explant dates. Below is the percentage distribution of mechanical lifespan among these 55 failed samples:
≤1 year: 9%
2–5 years: 40%
6–10 years: 33%
11–15 years: 13%
16–20 years: 5%
Median lifespan: 6 years
Mean lifespan: 6.5 years
Maximum lifespan: 19 years
20-Point Summary
- Infection is the top clinical driver — 18 reports. Devices were explanted, often replaced with a Genesis malleable. Manufacturer narratives repeatedly state sterilization was validated and infection likely came from non-device sources.
- Tubing failure dominates mechanical complaints — 22 reports of fracture, break, tear, fray, or rupture, most commonly at the pump junction or near cylinders.
- Fluid loss / leaks — 13 reports. Patients noted loss of saline, hissing sounds, or inability to maintain inflation.
- Erosion / extrusion — 12 reports. Includes pump eroding through scrotum, tubing eroding through skin, cylinders extruding through urethral meatus, and lateral wall erosion.
- Pain, discomfort, or patient preference — 10 reports. Examples: pain near pump, reservoir bothering patient, or elective change from inflatable to malleable.
- Unspecified malfunction — 10 reports list only "unknown malfunction," "unspecified reason," or "device not working" with no further detail.
- Reservoir complications — 8 reports. Reservoir migration, herniation, extrusion, originally placed in wrong spot, or needing adjustment.
- Pump problems — 8 reports. Pump repositioned for being too high, pump stiff and won't pump, blocked activation/deactivation, and auto-inflation.
- Incorrect sizing — 7 reports. Undersized 18cm cylinders replaced with 20cm, 26cm replaced with 28cm, pump placed "too short," and surgeon dissatisfaction with tubing length.
- Failure to inflate — 6 reports. Cylinders would not fill, pump stays firm after 3 pumps, or "not cycling" with associated pain.
- Age-related revisions — 6 reports explicitly cite device age: 8, 13, and 15-year-old implants replaced electively with no defect found.
- Intraoperative damage — 6 reports. Cylinder material snapped while using pusher, eyelet punctured during implant, and one pump could not be prepped due to suspected fracture/air.
- Urethral injury / fistula — 5 reports. Includes urethral perforation during initial surgery, fistula with urine leaking into testicle, and staged repairs after cylinder extrusion.
- Cylinder pinhole / crack — 3 reports. One case confirmed by photo/video showing micro-hole in distal cylinder causing leak.
- Cylinder migration / malposition — 3 reports. Cylinders not reaching glans, or right cylinder sitting in wrong position.
- Cylinder aneurysm — 2 reports. One is a detailed case from Peyronie's disease with prior pericardial graft, requiring proximal extracapsular tunneling and graft-on-graft reinforcement.
- Kinked tubing — 1 report where tubing kink prevented inflation; tubing was trimmed, reconnected, pump reseated, device left in situ.
- Auto-inflation — 3 distinct reports of device re-inflating minutes after deflation, attributed to defective auto-inflate valve.
- Transgender anatomical incompatibility — 1 report notes current pump is too bulky with sharp corners, surgeons file them down; single cylinder's pointed tip causes partner pain and limits phalloplasty outcomes.
- Clinical literature — 2 entries
- WMSM 2026 abstract: 66-year-old Peyronie's patient developed large cylinder aneurysm 2.5 years after grafted IPP; revision used proximal extracapsular tunneling + graft-on-graft Tutopatch to equalize corpora to 20cm and successfully re-implant.
- NGS vs culture study (Henry et al., TAU 2025, DOI 10.21037/TAU-2025-57): In 9 men with early low-grade IPP infection, 6/9 failed antibiotics and needed explant within 7 days — shaft tenderness predicted early failure; study compares NGS to traditional cultures.
- WMSM 2026 abstract: 66-year-old Peyronie's patient developed large cylinder aneurysm 2.5 years after grafted IPP; revision used proximal extracapsular tunneling + graft-on-graft Tutopatch to equalize corpora to 20cm and successfully re-implant.
**UPDATE**
Of the mechanically malfunctioned devices, only 55 of them had documented implant and explant dates. Below is the percentage distribution of mechanical lifespan among these 55 failed samples:
≤1 year: 9%
2–5 years: 40%
6–10 years: 33%
11–15 years: 13%
16–20 years: 5%
Median lifespan: 6 years
Mean lifespan: 6.5 years
Maximum lifespan: 19 years