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

Model Number	720074-03
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis presented with difficulty with penetration, pain, a lack of firmness in the penis, and bends in the penis.Physical examination of the patient revealed there were signs of a fracture in the distal third of the left rod, crepitus, and lack of support accompanied by lateral torsion.A revision surgery has been scheduled.No additional information was provided.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.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.A risk review was completed and confirmed that the event of disfigurement, pain, fracture, and mechanical issue were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk for the product.The reported patient symptoms of disfigurement and pain are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis presented with difficulty with penetration, pain, a lack of firmness in the penis, and bends in the penis.Physical examination of the patient revealed there were signs of a fracture in the distal third of the left rod, crepitus, and lack of support accompanied by lateral torsion.A revision surgery has been scheduled.No additional information was provided.

• 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: 24596360
• Report Number: 2124215-2026-14048
• Device Sequence Number: 12910614
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: (01)00878953005294(11)170227(17)220213(10)165487005
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 02/13/2022
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0165487005
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 02/27/2017
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male