Spectra RTE Kit 720170-01Recalls & reported problems
American Medical Systems, Inc. · Rear Tip Extender Kit 2 Each - 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953005393), received between Nov 30, 2017 and Nov 30, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS LATER REPORTED THE PHYSICIAN ATTEMPTED TO "REMOVE/REPOSITION ONE PENILE CYLINDER (AND THE REAR TIP EXTENDER) DETACHED IN THE PROCESS." IT WAS NOT LOCATED AND IS NOTED AS REMAINING IN THE PATIENT. A DIFFERENT REAR TIP EXTENDER WAS USED IN THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 7070765 ↗
Other Prosthesis, Penile devices
- TACTRA 720081-01Boston Scientific Corporation · PROSTHESIS, PENILE150 reports
- Spectra 720074-02American Medical Systems, Inc. · Prosthesis, Penile97 reports
- Genesis 91-9511SCColoplast A/S · PROSTHESIS, PENILE85 reports
- TACTRA 720080-01Boston Scientific Corporation · PROSTHESIS, PENILE61 reports
- TACTRA 720082-01Boston Scientific Corporation · PROSTHESIS, PENILE49 reports
- Genesis 91-9509SCColoplast A/S · PROSTHESIS, PENILE49 reports
- Spectra 720074-03American Medical Systems, Inc. · Prosthesis, Penile47 reports
- Spectra 720054-02American Medical Systems, Inc. · Prosthesis, Penile44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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