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

Model Number	720074-02
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this spectra malleable penile prosthesis was dissatisfied with the device, stating that it was bending too easily.A surgical procedure was performed in which the spectra was removed and replaced with a tactra malleable penile prosthesis.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this spectra malleable penile prosthesis underwent a thorough analysis.Both cylinders were microscopically inspected.Microscope examination revealed that both cylinders had holes and tool damage in the distal end of the cylinders consistent with sharp instrument damage.Based on the available test results and investigation, the allegations of device operating differently than expected and mechanical issue could not be confirmed.The damage identified on the cylinders was consistent with sharp instrument damage and was most likely introduced during the explant procedure.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this spectra malleable penile prosthesis was dissatisfied with the device, stating that it was bending too easily.A surgical procedure was performed in which the spectra was removed and replaced with a tactra malleable penile prosthesis.There were no patient complications 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: 23155761
• Report Number: 2124215-2025-67505
• Device Sequence Number: 10145488
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: (01)00878953005287(11)190521(17)240519(10)1000278639
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 05/19/2024
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000278639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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: 78 YR
• Patient Sex: Male