MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3544650
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number (b)(4).Upon receipt by mentor, the device contained clear gel.White material was observed within the device and gel and brown material on the shell surface.Upon receipt the device was severely rented.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, pe was precluded from further evaluating the device.No other anomalies were discovered.Complaint was confirmed.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet; however, complaint trends for mentor devices will continue to be monitored by quality assurance.Mentor performs 100% inspection and testing of all devices prior to release.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: left rupture.(b)(4).
Event or Problem Description
This report contains supplemental information for mentor psr reference number (b)(4).It was reported that a (b)(6) year-old female patient underwent primary breast augmentation with a 650cc mentor memorygel breast implant and experienced breast implant rupture on her left side postoperatively.As a result, the device was explanted on (b)(6) 2017.On (b)(6) 2020, mentor became aware that patient replacement surgery on (b)(6) 2020.Upon further clarification request, on (b)(6) 2020, mentor became aware that the explant was on (b)(6) 2017.
Additional Manufacturer Narrative
On november 12, 2020, mentor became aware that device return information under fields d10 were incorrectly reported as not returned under the previous submission.It has been corrected on this form.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) 2020, mentor became aware that field g3 was mistakenly left blank under the previous submissions.It has been corrected as "is report source health professional" has been selected on this form.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10829245
• Report Number: 1645337-2020-14482
• Device Sequence Number: 13928676
• Product Code: FTR
• UDI-Device Identifier: 00081317001140
• UDI-Public: 00081317001140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2020

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: 04/30/2018
• Device Model Number: 3544650
• Device Catalogue Number: 3544650
• Device Lot Number: 6706172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 11/16/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/12/2020; 11/16/2020
• 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
• Patient Age: 27 YR