MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720074-03

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 08/24/2016

Event Type  Injury  

Event Description

It was reported that following the implantation of his spectra device, the patient "was having issues using the device and associated discomfort"."upon examination after the patient was anesthetized, it was apparent that the rods, or at least one of them, was not seated properly and causing a distortion to the phallus.Upon accessing and removing the two rods via an infrapubic incision, it was observed that one had been fractured somehow, and the outer sheath had been damaged to the point that the inner linkages of the device were visible circumferentially".Following the device removal, the patient was implanted with an inflatable penile prosthesis.No further patient complications were reported in relation with this event.

Manufacturer Narrative

The explanted spectra cylinders were returned for evaluation - the analysis results indicate one cylinder's outer tube was separated into two parts as a result of fatigue and avulsion.The other cylinder functions as intended.Both cylinders sustained damage that occurred during the removal of the device.The circumstances surrounding the damage are unknown.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5959314
• MDR Text Key: 54993664
• Report Number: 2183959-2016-00162
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

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: 12/09/2018
• Device Catalogue Number: 720074-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR