MAUDE Adverse Event Report: MENTOR TEXAS CPX4 PLUS SM TE MH 800CC; EXPANDER, SKIN, INFLATABLE

Catalog Number SCPX156MH

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

One mentor cpx4 plus, smooth, medium height was received by the mentor failure analysis lab on november 7, 2023 with no accompanying information.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, the return of a prosthesis is characteristic of a removal and replacement surgery.As a result, this will be conservatively reported to fda.

Manufacturer Narrative

Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned device determined a rupture on the anterior view, between the shell and bladder of the cpx4 plus sm te mh 800cc tissue expander was observed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: CPX4 PLUS SM TE MH 800CC
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18268057
• MDR Text Key: 329739749
• Report Number: 1645337-2023-14285
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCPX156MH
• Device Lot Number: 9742196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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