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

Model Number 720056-03

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

This initial report was not able to be submitted on -time by boston scientific because of delayed acknowledgments from fda.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.

Event Description

It was reported that the patient underwent a spectra penile prosthesis (spp) replacement surgery due to a fracture in the device.All components were removed and replaced.There were no patient complications.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16828085
• MDR Text Key: 314154958
• Report Number: 2124215-2023-09947
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2023
• Device Model Number: 720056-03
• Device Catalogue Number: 720056-03
• Device Lot Number: 1000071534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR