MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

Catalog Number	EN8918
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
Event or Problem Description
According to the available information, the implant was removed and replaced due to a tubing fracture by the cylinder.
Event or Problem Description
According to the available information, the implant was removed and replaced due to a tubing fracture by the cylinder.
Additional Manufacturer Narrative
Titan pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and inlet tubes of the pump.Partial separations, surrounded by abrasion, were noted on the longer exhaust tube of the pump.These were not sites of leakage.The surfaces of the detachment site of the longer exhaust tube of the pump appear to be rough and irregular, indicating stress was exerted.A failure of the back pressure test was noted with the pump as the balls in the pump failed to seat properly.It was determined that foreign material was noted in the spring/ball and seat component of the pump.Abrasion was noted on both exhaust tubes of the cylinders.No functional abnormalities were noted with either cylinder 1 or cylinder 2.Abrasion was noted on the inlet tubing of the reservoir.A failure of the lock out reservoir valve seating test was noted with the reservoir as the poppet failed seat properly.It was determined that foreign material was noted in the seat component of the reservoir.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.While no functional abnormalities were noted during testing with the returned components, microscopic examination of the surfaces of the exhaust tube detachment end between the pump and cylinder 2 revealed rough and irregular surfaces, indicating stress was exerted.Based on the overlapping of the pump tubes, in combination with device usage over time, this could contribute to sufficient stress to separate the exhaust tubing of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.It was concluded that the foreign material noted in the spring/ball and seat component of the pump and in the poppet of the reservoir resulted in the failure of the back pressure testing and lock-out reservoir valve seating tests respectively.Because these components were released according to manufacturing and quality control procedures, it was concluded that the foreign material observed most likely entered the system after the device packaging was opened.Failure of this test was not associated with the cause of the reported device malfunction.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24608556
• Report Number: 2125050-2026-00395
• Device Sequence Number: 9640279
• Product Code: FHW
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 07/31/2024
• Device Catalogue Number: EN8918
• Device Lot Number: 7007421_EN89182400
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2019
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Unknown