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); Scar Tissue (2060); Unspecified Tissue Injury (4559)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this spectra concealable penile prosthesis (spp) experienced erosion on right distal corporal body.As a result, the device was explanted and replaced with an inflatable penile prosthesis (ipp).No further patient complications were reported.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.A dhr and ship history review cannot be performed as the lot number is not available.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of erosion 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 provided and the investigation conducted, adverse event related to patient condition was chosen, which means the patients condition, disease, or anatomy is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced the adverse event.

• 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: 25661392
• Report Number: 2124215-2026-34730
• Device Sequence Number: 12203631
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: (01)00878953005294(11)190513(17)240511(10)1000275007
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 05/11/2024
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 1000275007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 06/29/2026; 08/31/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 07/27/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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: 63 YR
• Patient Sex: Male