Spectra 720056-03Recalls & reported problems
American Medical Systems, Inc. · Concealable Penile Prosthesis, 2 Cylinders · Class 2 · Implant
All models of Spectra (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an implantable two-cylinder penile prosthesis made by American Medical Systems under the Spectra name. There are 25 adverse event reports naming its identifier, with no deaths and 24 injuries. Reports mostly describe the device breaking or needing surgical removal and replacement, along with pain, discomfort, infection, and movement or perceived shortening after implant. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00878953005256), received between Sep 20, 2017 and May 23, 2025 — classified as 24 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information8
- Adverse Event Without Identified Device or Use Problem5
- Inadequacy of Device Shape and/or Size5
- Mechanical Problem4
- Fracture2
- Defective Device1
- Device Operates Differently Than Expected1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Information4
- No Known Impact Or Consequence To Patient4
- Pain4
- Discomfort3
- Insufficient Information2
- Deformity/ Disfigurement1
- Dyspareunia1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH A SPECTRA PENILE PROSTHESIS (SPP) EXPERIENCED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE SPP AND REPLACE IT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 22078602 ↗InjuryOct 9, 2024Mechanical Problem; Inadequacy of Device Shape and/or Size; Defective Device; Mechanical Problem; Inadequacy of Device Shape and/or Size; Defective Device
IT WAS REPORTED THAT THE PATIENT, ENROLLED IN IT MATTERS CLINICAL STUDY WITH THIS SPECTRA PENILE PROSTHESIS, SUSPECTS THAT THEIR PENIS IS SHORTER THAN IT WAS PRIOR TO IMPLANT SIX MONTHS AGO. THE PATIENT IS UNABLE TO USE THE DEVICE AS OFTEN AS THEY LIKED. THE PHYSICIAN BELIEVED THAT THERE ARE NO DEVICE ISSUES, AND THE OUTCOME IS BASED ON THE SUBJECTIVE OPINION OF THE PATIENT. AT THE TWELVE-MONTH FOLLOW-UP, THE PATIENT REPORTED THAT THE DEVICE MOVES INTO THE BODY AND IS TOO FLEXIBLE WHEN ATTEMPTING SEXUAL INTERCOURSE. THE MOVEMENT INTO THE BODY SHORTENS THE LENGTH OF THE PENIS AND THE PATIENT IS UNABLE TO USE THE DEVICE. THE PHYSICIAN LATER SUSPECTED THE DEVICE WAS NOT WORKING AND DISCOVERED THE CYLINDERS WERE TOO SHORT AND LACKED RIGIDITY. THE PHYSICIAN REPLACED THE DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406480 ↗InjuryJul 31, 2024Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE IT MATTERS CLINICAL STUDY AND IMPLANTED WITH A SPECTRA PENILE PROSTHESIS ON (B)(6) 2023. THE PATIENT PRESENTED A MONTH LATER WITH RIGHT SIDED, DEEP PERINEUM PAIN THAT OCCURRED WHEN THE IMPLANT WAS MOVED TO THE LEFT, AS WELL AS LOCALIZED PAIN TO THE ISCHIAL TUBEROSITIES. THE PATIENT WAS PRESCRIBED MEDICATION. THE PATIENT ALSO EXPERIENCED DIFFICULTY CONCEALING THE ERECTION. A COUPLE MONTHS LATER, THE PATIENT PRESENTED WITH FLOPPY GLANS THAT THE PHYSICIAN SUSPECTED WAS RELATED TO AN UNDERSIZED CYLINDER. APPROXIMATELY A YEAR LATER, THE DEVICE WAS EXPLANTED AND REPLACED WITH LONGER CYLINDERS. UPON EXPLANT, THE PHYSICIAN FOUND THE RIGHT DISTAL CYLINDER HAD MIGRATED. SHORTLY AFTER THE PROCEDURE, THE RIGHT CYLINDER STILL DEMONSTRATED RIGHT LATERAL DISPLACEMENT AND A PENOPLASTY WAS PERFORMED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Deformity/ Disfigurement; Pain
MAUDE report 19874647 ↗InjuryFeb 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, PRIOR TO DISCHARGE FOLLOWING THE IMPLANT OF THIS SPECTRA PENILE PROSTHESIS, THE PATIENT DEVELOPED A SCROTAL HEMATOMA. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Hematoma
MAUDE report 18784816 ↗InjuryJul 11, 2023Noise, Audible; Noise, Audible
IT WAS REPORTED, THAT THE PATIENT STATED, THAT HE CAN HEAR CREAKING OF THIS SPECTRA PENILE PROSTHESIS. AND IN ADDITION, HE IS EXPERIENCING DISCOMFORT AND AN INCREASE OF SENSITIVITY IN THE REGION OF THE GLANS AND PERINEUM. IMAGING TESTS WERE PERFORMED. DURING WHICH, IT WAS IDENTIFIED AN ASYMMETRY IN THE GLANS AND A SHORTENING WITH A FOLD IN THE PERINEUM. A REVISION SURGERY HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Insufficient Information
MAUDE report 17301732 ↗InjuryApr 27, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPECTRA PENILE PROSTHESIS (SPP) REPLACEMENT SURGERY DUE TO A FRACTURE IN THE DEVICE. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828085 ↗InjuryApr 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS SPECTRA PENILE PROSTHESIS (SPP) FOR UNSPECIFIED REASONS. ALL COMPONENTS OF THE EXISTING SPP WERE EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811463 ↗InjuryApr 5, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS WAS BROKEN. THE PATIENT EXPERIENCED LOCAL PAIN AND CONTINUOUS DISCOMFORT WHICH MADE INTERCOURSE IMPOSSIBLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort; Dyspareunia; Pain
MAUDE report 16685597 ↗InjuryDec 14, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SPECTRA PENILE PROSTHESIS DUE TO THE DEVICE BEING TOO SMALL FOR THE PATIENT. A NEW SPECTRA WAS IMPLANTED WITH LONGER REAR TIP EXTENDERS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15977116 ↗InjuryAug 12, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT LOCAL PAIN AND CONTINUOUS DISCOMFORT WITH AN SPECTRA PENILE PROSTHESIS (SPP) MAKING RELATIONSHIPS IMPOSSIBLE. AN X-RAY WAS TAKEN DEMONSTRATING THE RIGHT CYLINDER WAS FRACTURED. THE SPP NEEDS TO BE REPLACED; HOWEVER, THE PROCEDURE HAS NOT BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Discomfort; Pain
MAUDE report 15220199 ↗MalfunctionMar 8, 2022Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole
IT WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS (SPP) WAS FRACTURED IN THE MEDIAL PORTION OF THE CYLINDERS. A SURGICAL PROCEDURE WAS SCHEDULED TO ADDRESS THE SPP ANOMALY; HOWEVER, THERE IS NO EVIDENCE THE INTERVENTION HAS BEEN PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13696215 ↗InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL INTERVENTION SIX MONTHS AFTER AN SPECTRA WAS IMPLANTED IN WHICH IT WAS REPLACED BY AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 12095808 ↗InjuryDec 2, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) WAS EXPLANTED BECAUSE IT WAS "DEFECTIVE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9397156 ↗InjuryAug 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT REPLACEMENT SURGERY OF AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) DUE TO EXCESSIVE INTRACORPORAL PRESSURE. A LARGER 14 MM BY 20 CM SPP WAS REMOVED AND REPLACED WITH SMALLER 14 MM BY 16 CM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8899078 ↗InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS SPECTRA PENILE PROSTHESIS (SPP) TO UPGRADE TO AN INFLATABLE PENILE PROSTHESIS (IPP). THE SPP WAS REMOVED AND AN IPP WAS THEN IMPLANTED WITHOUT COMPLICATION. THE EXPLANTED SPP WAS RETURNED AND ANALYZED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8599706 ↗InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUE WITH THE SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP). THE SPP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8223262 ↗InjuryJan 7, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) LENGTH. THE SPP WAS REMOVED AND REPLACED WITH AMBICOR PENILE PROSTHESIS. NO COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8222967 ↗InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN ON THE RIGHT SIDE WITH A SPECTRA PENILE PROSTHESIS (SPP). THE SPP WAS EXPLANTED AND A NEW 18CMX12MM INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Pain
MAUDE report 8219581 ↗InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7788188 ↗InjuryJul 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS REMOVED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7684784 ↗InjuryJul 3, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS CYLINDERS HAD MIGRATED PROXIMALLY, RESULTING IN A REDUCTION OF PENILE SIZE. NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7660836 ↗InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD HIS SPECTRA CONCEAL PENILE PROSTHESIS REPLACED WITH A 3 PIECE INFLATABLE PENILE PROSTHESIS DUE TO PATIENT DISSATISFACTION: "SPECTRA BENDS UPON PENETRATION". NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.
Patient problems: Therapeutic Response, Decreased
MAUDE report 7612854 ↗InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS REMOVED DUE TO CAUSING A CURVATURE OF THE PENIS. NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7319751 ↗InjuryDec 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS DUE TO "PATIENT NOT SATISFIED WITH SPECTRA." NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7080041 ↗InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD HIS RIGHT SPECTRA PENILE PROSTHESIS CYLINDER REMOVED AND REPLACED DUE TO EROSION AT "GLANS/DISTAL URETHRA." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Erosion
MAUDE report 6878333 ↗
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
- Genesis 91-9509SCColoplast A/S · PROSTHESIS, PENILE49 reports
- TACTRA 720082-01Boston Scientific Corporation · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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