- Concealability Issue (1): A patient was dissatisfied with the device's concealability; it was explanted and replaced with an Ambicor prosthesis.
- Unspecified Explant (1): The device was removed and replaced with an inflatable penile prosthesis (IPP) with no further details provided.
- Perforation & Malfunction (1): A patient experienced crural perforation, inadequate rigidity, and bending; the device was surgically replaced.
- Structural Failure (1): A cylinder broke when bone anchors tore through the silicone; it was replaced with an IPP.
- Implanted as a Replacement (2): In two separate cases, a new Tactra device was implanted after the removal of a previous Genesis device.
Genesis (3 Total Events)
- Size Upgrade (1): A device was swapped for a new Genesis prosthesis based on patient preference after the patient gained length.
- Unknown Surgical Removal (2): In two distinct reports, the device was removed during surgery for unknown reasons and replaced with a Tactra implant.
Source:
https://www.fda.gov/medical-devices/med ... data-files
Disclaimer
The MAUDE database contains reports of adverse events involving medical devices submitted to the FDA. A submitted report does not necessarily reflect a conclusion by the FDA or the reporter that the device caused or contributed to the event. Reports may be incomplete, inaccurate, unverified, or biased and have not been evaluated by the FDA. MAUDE data cannot be used to determine event rates or to compare safety between devices.
