BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11962900 · Received June 8, 2021

    Report

    Report Number
    1645337-2021-06470
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 13, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. MANUFACTURING RECORD EVALUATION FOR LOT #: 5778383: MANUFACTURED DATE: 11-OCT-2007. EXPIRATION DATE: 10-OCT-2011. MANUFACTURING RECORD EVALUATION FOR LOT #: 5842852: MANUFACTURED DATE: 31-JUL-2008. EXPIRATION DATE: 30-JUL-2012. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 19-AUG-2021, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE SUSPECTED MEDICAL DEVICE. THE LOT AND SERIAL NUMBERS ARE 5778383 AND (B)(6) RESPECTIVELY. THE RELEVANT FIELDS HAVE BEEN UPDATED. THE SUSPECTED MEDICAL DEVICE WAS RETURNED FOR EVALUATION. ON 23-AUG-2021, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS COMPLETED. INVESTIGATION SUMMARY: MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE DETERMINED THAT THE VALVE OF THE BREAST IMPLANT WAS MISSING. A MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE RUPTURE AROUND THE MISSING VALVE COULD NOT BE IDENTIFIED. MENTOR DID NOT RECEIVE PERMISSION TO PERFORM DESTRUCTIVE TESTING.  AS A RESULT, THE ANALYSIS FROM THE PRODUCT EVALUATION LAB WAS LIMITED TO NON-DESTRUCTIVE TESTING, AND WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE RUPTURE. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: CAUSES OF DEFLATION OF SALINE IMPLANTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, ETC. 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 · 1

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE PATIENT STATED THAT MAMMOGRAM PERFORMED ON UNSPECIFIED DATE INDICATED RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO UNSPECIFIED SALINE BREAST IMPLANTS ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2021 BASED ON AVAILABLE INFORMATION. THE LOT NUMBER AND SERIAL NUMBER OF THE COMPLAINT DEVICE ARE EITHER (B)(4) AND EITHER (B)(4) RESPECTIVELY. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859001 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 5778383 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention