MAUDE Adverse Event Report: MENTOR TEXAS CPX4 PLUS SMOOTH MEDIUM HEIGHT 350CC; EXPANDER, SKIN, INFLATABLE

Model Number	SCPX117MH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent an unspecified breast surgery with an unknown tissue expander breast implant experienced unknown-sided deflation post procedure.The issue was confirmed by the health care professional.As a result, patient underwent removal on (b)(6), 2022.
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number: pc-(b)(4).
Additional Manufacturer Narrative
Additional information received on march 11, 2022 indicated that the suspect device serial number is (b)(6), cat#: scpx117mh, date of implantation was on (b)(6) 2021, patient age at the time of event was 41 years patient ethnicity is african american.The patient right-side was affected.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on june 20 , 2022: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and leak test of the returned device.During the visual analysis of the returned sample cpx4 plus smooth medium height 350cc, no apparent damage or visual anomalies were observed.Leak testing was performed, in accordance with mentor procedures, and revealed a leakage, caused by delamination dome.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: CPX4 PLUS SMOOTH MEDIUM HEIGHT 350CC
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13695533
• Report Number: 1645337-2022-02483
• Device Sequence Number: 13849188
• Product Code: LCJ
• UDI-Device Identifier: 10081317028366
• UDI-Public: 10081317028366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: Health Professional
• Device Expiration Date: 05/06/2025
• Device Model Number: SCPX117MH
• Device Catalogue Number: SCPX117MH
• Device Lot Number: 9576488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 03/20/2022; 03/28/2022; 04/08/2022; 05/25/2022; 06/20/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/23/2022; 03/25/2022; 04/04/2022; 04/28/2022; 06/09/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American