2026 March Malleable MAUDE Adverse Events Summary

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lasthope2.0
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Joined: Sat Oct 11, 2025 1:23 pm

2026 March Malleable MAUDE Adverse Events Summary

Postby lasthope2.0 » Mon May 04, 2026 6:43 pm

Genesis

  1. Infection and distal erosion in a high-risk patient: Patient had prior prosthesis infection and a history of delayed wound healing from orthopedic surgeries. A Genesis malleable was placed temporarily to keep corporal space open, but it eroded distally through the urethral meatus and there was a non-healing drain-tube wound. The device was also found to be infected. It was explanted and the corpora were left empty to heal. Patient is using a vacuum erection device and tadalafil to preserve length, with re-implantation planned for ~2026.
  2. Unspecified malfunction: Device malfunctioned, was explanted and replaced with another Genesis.

Tactra

  1. Sizing issue – rolling: Implant never stayed upright, it just rolled. Explanted and replaced with a bigger Tactra.
  2. Erosion from thin tissue: Patient with thin corporal tissue developed erosion. Device explanted and replaced with a smaller Tactra.
  3. Inadequate rigidity: Patient reported erection not firm enough. Tactra explanted and converted to an inflatable penile prosthesis (IPP).
  4. Mechanical bending failure: Right cylinder showed incomplete bending and abnormal angle. Intra-op findings: lateral right corpora abnormally thin, cylinder had migrated. Surgeon implanted a new Tactra on the right only, retained the left original, and reinforced the thin area with 3-0 PDS suture.
  5. Dissatisfaction – penile curvature: Tactra resulted in curvature the patient found unsatisfactory. Device removed and replaced with IPP. No device issues or complications reported.
  6. Dissatisfaction – concealability: Patient disliked constant rigidity and preferred a three-piece implant for better concealment. Tactra explanted and replaced with three-piece IPP.
  7. Unspecified revisions converted to IPP: Three separate reports listed only "unspecified reasons" for surgery. In each, the Tactra was explanted and replaced with an IPP. No additional details provided.
  8. Unspecified Tactra-to-Tactra revisions: Four reports noted replacement surgery for unstated reasons with no complications. In two cases the device was simply replaced with another Tactra, in the others details were not provided.

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