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

Model Number	720074-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a work accident which caused the spectra inflatable penile prosthesis to erode through his penis.The implant was removed in (b)(6) 2019.A tactra 9.5mm was implanted on (b)(6) 2020.The patient was doing fine following the reimplant surgery.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11061582
• Report Number: 2183959-2020-06056
• Device Sequence Number: 19104513
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/20/2021
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0141133005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR