Spectra 720056-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00878953005249), received between May 15, 2018 and Apr 7, 2023 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT, PER THE PATIENT, THIS SPECTRA PENILE PROSTHESIS DOES NOT MAINTAIN SUFFICIENT RIGIDITY AND DOES NOT ALLOW HIM TO MAINTAIN AN ERECTION DURING INTERCOURSE. A REVISION SURGERY IS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702606 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE SPECTRA PENILE PROSTHESIS (SPP) EXPERIENCED EROSION IN RIGHT CORPORA CAVERNOSA. AFTER APPROXIMATELY SIX MONTHS PRIOR THE EROSION DIAGNOSIS, A SURGICAL PROCEDURE WAS PERFORMED, WHEREIN THE SPP WAS REMOVED AND REPLACED WITH A TACTRA MALLEABLE PENILE PROSTHESIS. IT WAS LATER REPORTED THAT VASCULAR DISEASE MAY HAVE CONTRIBUTED TO THE EROSION. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 14257098 ↗
• MalfunctionOct 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PAIR OF SPECTRA PENILE PROSTHESIS (SPP) CYLINDERS WERE NOT USED BECAUSE THEY WERE NOT ABLE TO ATTACH ANY REAR TIP EXTENDER'S (RTE'S) TO THEM. THIS WAS THE SECOND DEVICE THAT WAS ATTEMPTED TO BE USED DURING THE IMPLANT SURGERY. A NEW PAIR OF CYLINDERS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10681752 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A SPECTRA MALLEABLE PENILE IMPLANT SURGICAL PROCEDURE. THE PATIENT REMAINED HOSPITALIZED FOR 24 HOURS WITH INTRAVENOUS ANTIBIOTHERAPY, CEFTRIAXONE AND GENTAMICIN, RECOMMENDED DOSE. HE WAS DISCHARGED IN GOOD CLINICAL CONDITION WITH CHARACTERISTIC PENILE EDEMA. FOLLOW-UP WAS PERFORMED ON AN OUTPATIENT BASIS, 48 HOURS AFTER THE PROCEDURE. THE PATIENT CONTINUED COMPLAINTS OF PAIN IN THE BODY OF THE PENIS AND IN THE SUPRA PUBIC AREA AND EDEMA WAS MAINTAINED, THE PATIENT WAS TREATED WITH OTHER ANTIBIOTICS AND ANALGESICS. AFTER 10 DAYS, EDEMA WAS NOTED WITH AN ABSCESSED AREA OF THE BACK OF THE PENIS. THE PATIENT WAS HOSPITALIZED, CULTURES AND ANALYTICS WERE TAKEN TO MANAGE WITH CONJECTURE, AND TREATMENT WAS APPLIED ACCORDING TO THE ANTIBIOGRAM. THE PATIENT WAS ASSESSED WHETHER TO MAINTAIN THE PROSTHESIS BUT WAS NOT IMPROVING AS THERE WAS PURULENT DISCHARGE FROM THE DORSAL AREA OF THE PENIS AND SUPPURATION, A SEROPURULENT MATERIAL. IT WAS DECIDED TO REMOVE THE IMPLANT. DURING THE REMOVAL OF THE MALLEABLE IMPLANT, A LOT OF PURULENT MATERIAL AND EDEMA WERE NOTED IN THE PENILE AREA OR DUCTS. 15 DAYS AFTER THE SURGERY FOR THE IMPLANTATION OF MALLEABLE PROST

  Patient problems: Abscess; Edema; Pain; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 9929393 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS (SPP) WAS REMOVED DUE TO UNKNOWN REASON. A NEW SPP WAS IMPLANTED IN THE RIGHT SIDE ONLY. NO INFORMATION ABOUT THE PATIENT'S OUTCOME WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED. THE PATIENT PRESENTED A SMALL HOLE WITH DRAINAGE ON THE LATERAL ASPECT OF HIS PENIS. THERE WAS NO CYLINDER IN THE LEFT SIDE DUE TO SCARRING IN LEFT CORPORAL BODY. NO DEVICE MALFUNCTION WITH PREVIOUS SPP.

  Patient problems: Fluid Discharge; Perforation; Scarring

  MAUDE report 9897112 ↗
• InjuryMar 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) DEVICE IS GOING TO BE REVISED DUE TO AN INFECTION. THE PATIENT "CURRENTLY HAS A PROSTHESIS-ASSOCIATED INFECTION. THE CONDITION WAS CONFIRMED WITH AN ULTRASOUND EXAM, WHICH SHOWED COLLECTION AND INFLAMMATION, WITH DRUG TREATMENT, THE CASE WAS ALMOST COMPLETELY REVERSED, BUT REQUIRES SURGICAL TREATMENT. THE PROPOSED SURGERY IS RESCUE SURGERY, TRYING TO AVOID THE LOSS OF THE PENILE PROSTHESIS, THE PATIENT IS HOSPITALIZED RECEIVING ANTIBIOTICS AND WILL BE SUBMITTED TO PENILE PROSTHESIS RESCUE SURGERY ON FEBRUARY 23RD."

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9860963 ↗
• InjuryMay 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION WITH THE SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP). THE SPP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. NO FURTHER ISSUES WERE REPORTED IN RELATION TO THIS EVENT. THE PRODUCT WAS EXPLANTED AND NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Erosion

  MAUDE report 8637431 ↗
• InjuryApr 9, 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 ENTIRE SPP WAS REMOVED AND NOTHING WAS REIMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. THE PRODUCT WAS EXPLANTED AND NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496638 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ONLY THE LEFT CYLINDER OF A SPECTRA PENILE PROSTHESIS (SPP) DUE TO AN UNSPECIFIED REASON. FURTHER INFORMATION WAS REQUESTED BUT 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 8223061 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED DUE TO INFECTION. THE PATIENT WAS REIMPLANTED WITH A SPECTRA PENILE PROSTHESIS CYLINDER NO THE RIGHT SIDE ONLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7637025 ↗
• InjuryMay 15, 2018Migration or Expulsion of Device; Detachment of Device or Device Component; Insufficient Device Problem Information; Migration or Expulsion of Device; Detachment of Device or Device Component; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS REPLACED DUE TO "DETACHMENT FROM PUBIC BONE." THERE WAS "NO AXIAL RIGIDITY DUE TO DETACHMENT."

  Patient problems: No Information; Therapeutic Response, Decreased

  MAUDE report 7516115 ↗