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

Model Number	3541751
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the evaluation was performed on a photo of the suspect medical device.The physical device has not been received by mentor.According to the information provided, the patient experienced a rupture on the breast implant.Upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed on the device.As the product involved in this complaint was not received, the device couldn¿t be analyzed according to our procedures.If the device is received and analyzed, a supplemental report will be submitted.Although the product was not received, the manufacturing records of the lot-serial number provided were identified.The manufacturing records were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Rupture complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Reason for device explant and/or reoperation: left breast prosthesis rupture.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast augmentation revision procedure with a mentor memorygel breast implant 175cc gel breast prosthesis that ruptured after implantation.Rupture of the patient¿s left breast prosthesis was reported.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 2020, the mentor failure analysis lab 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
On (b)(6) 2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient experienced a rupture in the breast implant.During visual evaluation of the device, a tear was observed on the anterior aspect, measuring 8.4 cm.Please note that the product evaluation lab couldn¿t identify a conclusion due to the specific nature of this rupture and insufficient paperwork.The evaluation was limited to non-destructive testing.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Rupture complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.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: 10518359
• Report Number: 1645337-2020-11361
• Device Sequence Number: 14342099
• Product Code: FTR
• UDI-Device Identifier: 00081317000815
• UDI-Public: 00081317000815
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2020

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: 06/21/2022
• Device Model Number: 3541751
• Device Catalogue Number: 3541751
• Device Lot Number: 7480259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 11/17/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/29/2020; 11/18/2020
• 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: 34 YR