MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPECTRA; PROSTHESIS PENILE

Model Number	720074-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	01/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this spectra concealable penile prosthesis experienced an infection and erosion which led to evaluation and diagnosis in the emergency room.During revision surgery, the device was explanted and no further patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Erosion and infection are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.The reported patient symptoms of erosion and infection are known risk associated with this device type and indicated as such in the instructions for use.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) were reviewed.The patient symptoms erosion and infection were found to be listed in the ifu.The reported patient symptoms of erosion and infection are known risks associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the event of erosion and infection was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this spectra concealable penile prosthesis experienced an infection and erosion which led to evaluation and diagnosis in the emergency room.During revision surgery, the device was explanted and no further patient complications were reported.

• Brand Name: SPECTRA
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24422095
• Report Number: 2124215-2026-09957
• Device Sequence Number: 5879942
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: (01)00878953005294(11)131014(17)181001(10)850836004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 850836004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 10/14/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male