Spectra 720054-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00878953005218), received between Aug 31, 2017 and Nov 15, 2023 — classified as 39 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN INDICATING THIS SPECTRA PENILE PROSTHESIS WAS FRACTURED. THE CLINICAL EXAMINATION CONFIRMED THAT THE PROSTHESIS WAS NOT RIGID AND WAS MAKING NOISE RELATED TO FRICTION. NO FURTHER EXAMINATION WAS PERFORMED. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140479 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED AND EXPERIENCED DISCOMFORT AND PAIN IN THE IMPLANT SITE OF HIS MALLEABLE PENILE PROSTHESIS. THE PATIENT UNDERWENT SURGERY, AND THE PROSTHESIS WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort; Pain

  MAUDE report 17414034 ↗
• InjuryJun 14, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE AMS SPECTRA CONCEALABLE PENILE PROSTHESIS BECAUSE THE DEVICE WAS BENDING. THE DEVICE WAS REPLACED WITH A TACTRA MALLEABLE PENILE PROTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131443 ↗
• InjuryMar 29, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PATIENT WANTING MORE RIGIDITY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637026 ↗
• InjuryMay 25, 2022Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY WITH INSERTION DURING SEXUAL INTERCOURSE WITH A SPECTRA PENILE PROSTHESIS (SPP) . THE DEVICE CYLINDERS WERE REPORTED TO BEND, WHEN HAVING SEXUAL INTERCOURSE. THE SPP WAS EXPLANTED, AND A NEW SPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502123 ↗
• InjuryApr 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) WAS REMOVED AND REPLACED WITH A TACTRA DUE TO INCORRECT DEVICE SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079036 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOLLOWING EROSION AT THE DISTAL TIP OF THE PENIS INVOLVING THIS SPECTRA PENILE PROSTHESIS (SPP). UPON CONFIRMATION BY THE PHYSICIAN, A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE SPP WAS EXPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 13830441 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 A NEW TACTRA MALLEABLE PENILE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560701 ↗
• MalfunctionJan 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REQUEST WAS MADE TO EXPLANT AND REPLACE THIS SPECTRA PENILE PROSTHESIS DUE TO AN UNSPECIFIED DEVICE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233128 ↗
• InjuryNov 30, 2021Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SPECTRA PENILE PROSTHESIS (SPP) UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE DEVICE. THE DEVICE WAS TOO SMALL FOR THE CORRECT FIT IN THE CORPORA AND CAUSED THE CYLINDERS TO BECOME INDIVIDUALLY TWISTED. THE EXISTING SPP WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897245 ↗
• InjuryOct 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) WAS REMOVED AND REPLACED WITH A TACTRA DUE TO UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724161 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH HIS SPECTRA PENILE PROSTHESIS (SPP) DEVICE. HE UNDERWENT A SURGICAL INTERVENTION IN WHICH ALL COMPONENTS WERE EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 12459670 ↗
• InjuryAug 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REMOVED AS IT WAS BENT. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. FOLLOWING THE SURGERY, THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297401 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ORIGINAL SPECTRA PENILE PROSTHESIS (SPP) IMPLANT PROCEDURE THE PATIENT FELT PAIN LEADING TO THE DEVICE BEING REMOVED AND THE PROCEDURE ABORTED. THE PATIENT HAD BEEN SEDATED WHEN THE IMPLANT WAS CANCELLED. THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THE REMOVED DEVICE. THE PATIENT DID NOT EXPERIENCE ADDITIONAL ADVERSE EVENTS AND WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 12211358 ↗
• InjuryMay 26, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT IT WAS DIFFICULT TO SUSTAIN INTERCOURSE WITH HIS SPOUSE DUE TO THE SPECTRA PENILE PROSTHESIS (SPP) BENT. THE DEVICE WAS REPLACED WITH A NEW SPP. THE SIZE OF THE PREVIOUS DEVICE WAS APPROPRIATE FOR THE PATIENT. THE PATIENT IMPROVED AND HAD A GOOD OUTCOME FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885303 ↗
• InjuryFeb 8, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS LEFT 9.5MM X 16CM CYLINDER REPLACED WITH A 12MM X 16CM CYLINDER AS THE FRONT PART OF THE PENIS WAS BENT WHILE DURING SEX WITH A PARTNER. FOLLOWING THE REVISION SURGERY, THE PATIENT WAS STABLE, IMPROVED AND THE EVENT RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 11293748 ↗
• InjuryJan 21, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL TWO WEEKS BEFORE SURGERY, SAYING THE SPECTRA PENILE PROSTHESIS LENGTH WAS NOT CORRECT. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE LENGTH WAS NOT CORRECT. THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REPLACED AND EXTENDED THE TIP BY 1.5 CM. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE AND IMPROVED. THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11210426 ↗
• InjuryNov 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) WAS EXPLANTED DUE TO AN INFECTION. A NEW DEVICE WILL BE IMPLANTED IN APPROXIMATELY THREE MONTHS.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 10906302 ↗
• InjuryNov 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFLAMMATION AND PAIN NEAR THE GENITALS WITH AN SPECTRA PENILE PROSTHESIS (SPP). THE SPP WAS EXPLANTED AND THE PHYSICIAN TREATED THE INFLAMMATION AND A NEW SPP WAS IMPLANTED. THE CAUSE OF THE INFLAMMATION WAS UNKNOWN FROM THE HOSPITAL. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Inflammation; Pain

  MAUDE report 10824652 ↗
• InjuryMay 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REVISION OF AN SPECTRA PENILE PROSTHESIS(SPP) CYLINDER DUE TO THE LENGTH BEING TOO SHORT. A PATIENT OUTCOME OF STABLE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069440 ↗
• InjuryJan 8, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) PROCEDURE DUE TO THE PATIENT EXPERIENCED PAIN THE NEXT DAY AFTER SURGERY. THE PHYSICIAN BELIEVES THAT THE PATIENT HAD CROSS OVER OF THE SPP. THE DEVICE WAS REPLACED WITH A TACTRA WITHOUT ANY ISSUES AND FUNCTIONING AS DESIGNED. THE PATIENT HAD A GOOD OUTCOME WITH NO FURTHER COMPLICATIONS. NO MORE INFORMATION AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED.

  Patient problems: Pain; Perforation

  MAUDE report 9563695 ↗
• InjurySep 17, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND INCONVENIENCE WITH A SPECTRA PENILE PROSTHESIS (SPP). THE SPP WAS EXPLANTED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS. ADDITIONAL INFORMATION WAS REPORTED THAT THE PAIN BEGAN 3 WEEKS PRIOR TO REVISION SURGERY AND WAS LOCATED AT THE CONTACT LOCATION OF THE DISTAL TIP OF THE CYLINDER. THE PATIENT WAS ALSO EXPERIENCING SOME IRRITATION IN THE AREA OF PAIN.

  Patient problems: Irritation; Pain

  MAUDE report 9079147 ↗
• InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) IMPLANT SURGERY WAS SUSPENDED DUE TO URETHRAL INJURY DURING THE SURGERY. "THE CYLINDER AND RTE 5CM WERE JUST USED AND THERE'S NO ANY IMPLANTATION." ADDITIONAL INFORMATION RECEIVED STATES THE CAUSE OF THE URETHRAL INJURY WAS NOT SPECIFIED BUT "THE URETHRA OF THE PATIENT WAS NOT HEALTHY" DURING THE SURGERY. THERE WERE NO FURTHER COMPLICATIONS AS A RESULT OF THIS EVENT. PRODUCT WAS EXPLANTED AND EXPECTED TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED AFTER PRODUCT HAS BEEN RETURNED AND PRODUCT ANALYSIS HAS BEEN COMPLETED. IT WAS FURTHER REPORTED THAT THE URETHRAL INJURY WAS "A PERFORATION OF THE URETHRA DURING SURGERY." IT WAS ALSO CLARIFIED THAT WHAT WAS MEANT BY "THE URETHRA WAS NOT HEALTHY" MEANT THAT THE URETHRA WAS INJURED "WITH EXTERNAL WAY" WHICH WAS RELATED TO THE IMPLANT PROCEDURE.

  Patient problems: Complaint, Ill-Defined; Injury; Perforation

  MAUDE report 8939106 ↗
• InjuryAug 22, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THIS SPECTRA MALLEABLE PENILE PROSTHESIS DUE TO POOR RIGIDITY AND QUALITY OF ERECTIONS PREVENTING INTERCOURSE. THE EXISTING DEVICE WAS EXPLANTED AND AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED IN ITS PLACE. NO PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED COMPONENTS ARE EXPECTED FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924081 ↗
• InjuryAug 15, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) WAS EXPLANTED DUE TO AN INFECTION. A NEW DEVICE WILL BE RE-IMPLANTED "IN PROPER TIME." ADDITIONAL INFORMATION RECEIVED STATES THE SPP DEVICE "FAILED." PRODUCT WAS EXPLANTED AND EXPECTED TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED AFTER PRODUCT HAS BEEN RETURNED AND PRODUCT ANALYSIS HAS BEEN COMPLETED. IT WAS FURTHER REPORTED THAT THE INFECTION WAS LOCATED 0.5-1 CM BELOW THE "RIGHT SIDE OF SUB-CORONAL." THE PATIENT EXPERIENCED PAIN AND REDNESS TWO WEEKS AFTER IMPLANTATION. THE PHYSICIAN BELIEVES THE OPERATIVE PROCEDURE MAY HAVE LED TO THE WOUND INFECTION. BECAUSE THE INFECTION WAS RELATED TO WOUND HEALING THE PHYSICIAN BELIEVES THE INFECTION WAS MOST LIKELY STAPHYLOCOCCUS. ADDITIONALLY, THERE WAS NO COMPONENT FAILURE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8898371 ↗