MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT; EXPANDER, SKIN, INFLATABLE

Model Number	SCPX135MH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.  as such, the investigation will be closed.  if the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.  this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.  this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 550cc mentor cpx4 plus, smooth, medium height tissue expander was placed into the patient and inflated during a breast surgery.Subsequently, it was observed that the expander visibly deflated.Upon inspection, there was a hole on the expander patch.No further information was provided.There were no reported adverse events or patient consequences.
Additional Manufacturer Narrative
On september 25, 2023, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.Visual analysis of the returned sample revealed that the tissue expander have an area of delamination between the injection dome and the bladder, causing leakage.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.According to the manufacturing investigation, as part of the analysis for this device, a fourier transform infrared (ftir) spectroscopy was performed to evaluate the presence of a poly film protector.Analysis confirmed the presence of the polyethylene that is removed from the surfaces of the washer before being used to assemble the injection site to the shell.The customer complaint is considered a manufacturing defect since the process requests to remove the poly film protector before vulcanizing the injection dome.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 13, 2023, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.  when the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT
• Common Device Name: 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: 17032096
• Report Number: 1645337-2023-06360
• Device Sequence Number: 6909193
• Product Code: LCJ
• UDI-Device Identifier: 10081317028380
• UDI-Public: 10081317028380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: SCPX135MH
• Device Catalogue Number: SCPX135MH
• Device Lot Number: 9759861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 09/25/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/06/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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
• Patient Sex: Unknown