MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501480
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/05/2016
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: left deflation.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 62-year-old female patient underwent primary breast augmentation with unknown size unknown saline implants and experienced breast implant deflation on her left side postoperatively.The patient underwent bilateral explantation and replacement with catalog number 3501480; serial number (b)(4) on the left side, and with catalog number 3501480; serial number (b)(4) on the right side on (b)(6) 2016.
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, mentor became aware of the following and corresponding fields have been updated on this form: - date of event was july 5, 2016; field b3 has been updated - field d1 for brand name has been updated to "mentor smooth round spectrum" - field d4 for catalog number has been updated to "3501480" - lot number "6758479"has been added to field d4 - field d4 for serial number has been updated to (b)(6) - field d4 for unique identifier( udi) has been updated to - date of implant under field d6a has been updated to (b)(6) 2013 - date of replacement surgery was (b)(6) 2016.Hence, date of explant under field d6b has been updated to (b)(6) 2016 - field g4 for pma/ 510(k) has been updated to "p990075" a manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 22, 2022, mentor became aware that the device for this caucasian patient was discarded and not available for return.Type of investigation under field h6 has been updated to "device discarded" on this form.The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15188759
• Report Number: 1645337-2022-09157
• Device Sequence Number: 12256667
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: 00081317002024
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 09/30/2017
• Device Model Number: 3501480
• Device Catalogue Number: 3501480
• Device Lot Number: 6758479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 08/26/2022; 09/22/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 08/24/2022; 08/28/2022; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2013
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White