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

Model Number	720056-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, the reported device observation cannot be confirmed.The reported patient symptoms of pain and discomfort are known risks associated with implants of the spectra penile prosthesis as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced recurrent local pain and continuous discomfort with an spectra penile prosthesis (spp) making relationships impossible.An x-ray was taken demonstrating the right cylinder was fractured.The spp needs to be replaced; however, the procedure has not been performed.No additional information was reported.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, the reported device observation cannot be confirmed.The reported patient symptoms of pain and discomfort are known risks associated with implants of the spectra penile prosthesis as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced recurrent local pain and continuous discomfort with an spectra penile prosthesis (spp) making relationships impossible.An x-ray was taken demonstrating the right cylinder was fractured.The spp needs to be replaced; however, the procedure has not been performed.No additional information was reported.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15220199
• Report Number: 2124215-2022-30159
• Device Sequence Number: 5812184
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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: 67 YR
• Patient Sex: Male