- Mechanical Failure (1 event): A broken cylinder occurred where bone anchors tore through the silicone. The device was replaced with an IPP.
- Clinical Complications (1 event): A patient experienced crural perforation along with functional difficulties, including inadequate rigidity and bending. The device was surgically removed and replaced.
- Patient Dissatisfaction (1 event): A patient was unsatisfied with the concealability of the implant. It was removed and replaced with an Ambicor with no further complications.
- Unspecified Explantation (1 event): The device was explanted and replaced with an IPP. No additional clinical information or reasons were provided.
Genesis (Coloplast) – 4 Total Events
- Unspecified Replacements (2 events): Two separate reports note patients undergoing surgery for unknown reasons to remove an existing Genesis (or Promedon) device and replace it with a new Tactra implant.
- Clinical Complications (1 event): An extruded cylinder (associated with erosion) was reported. The extruded cylinder was removed, and the remaining system was capped.
- Sizing/Patient Preference (1 event): The device was removed and replaced with another Genesis device because the patient gained length and preferred a new size.
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.
