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

Model Number	720074-01
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient, enrolled in the it matters clinical study, with this spectra penile prosthesis (spp), presented with the device undersized; therefore, a replacement surgery was scheduled.No further information was provided.
Additional Manufacturer Narrative
Additional information updated: b5: describe event/problem b1: adverse event/product problem.B2: outcomes attrib to adv event.D6b: explant date.H1: type of reportable event.H6: patient codes, impact codes, evaluation conclusion codes.
Event or Problem Description
It was reported that the patient, enrolled in the it matters clinical study, with this spectra penile prosthesis (spp), presented with a floppy glans due to the device being undersized; therefore, a replacement surgery was performed, and the event was resolved.No further patient complications were reported.
Additional Manufacturer Narrative
Additional information updated: b5: evaluation conclusion codes.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis (spp) presented with a floppy glans due to the device being undersized; therefore, a replacement surgery was performed, and the event was resolved.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis (spp) presented with a floppy glans due to the device being undersized; therefore, a replacement surgery was performed, and the event was resolved.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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) was reviewed.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 20856965
• Report Number: 2124215-2024-76786
• Device Sequence Number: 8628091
• Product Code: FAE
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2024
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 1000319208
• Was Device Available for Evaluation?: No
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/21/2025; 04/22/2026
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/30/2024; 03/13/2025; 05/12/2026
• Date Device Manufactured: 08/16/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 158 LB