MAUDE Adverse Event Report: MENTOR TEXAS TALL HEIGHT TE 650CC; EXPANDER, SKIN, INFLATABLE

Model Number	3548315
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
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.Reason for device explant and/or reoperation: deflation, shell irregularities.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent an unspecified breast reconstruction surgery with mentor cpx 4 breast 650 cc tissue expander experienced unknown sided deflated post procedure.As a result, the expander was explanted on an unknown date, and explanted expander found to have a tear in the back pad.
Additional Manufacturer Narrative
Device video evaluation completed on october 8, 2021: upon visual evaluation of the images and video provided in the complaint, the tissue expander appears deflated.As the product involved in this complaint was discarded, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 6, 2021 mentor became aware that mistakenly reported in the initial report that the device to be returned.Manufacturer¿s reference number: (b)(4) the complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.

• Brand Name: TALL HEIGHT TE 650CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12586518
• Report Number: 1645337-2021-11156
• Device Sequence Number: 3375947
• Product Code: LCJ
• UDI-Device Identifier: 00081317006626
• UDI-Public: 00081317006626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 10/03/2023
• Device Model Number: 3548315
• Device Catalogue Number: 3548315
• Device Lot Number: 9376471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 10/08/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/06/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention