InjuryFAE
TACTRA
Received Jul 7, 2026 · Event occurred May 8, 2026
Report 2124215-2026-36267 · MDR key 25733152
Device
Generic name
Prosthesis Penile
Manufacturer
Boston Scientific CorporationModel number
720081-01Catalog number
720081-01
Lot number
0040357119
Product problems
- Fracture
Patient
Not reported
- Fibrosis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, DURING AN TACTRA IMPLANT SURGERY PROCEDURE, THE DEVICE HAD RUPTURED. ADDITIONALLY, THE PATIENT DEVELOPED FIBROSIS FROM PREVIOUS SURGERIES. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.