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

Model Number	3541408
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) hispanic female patient underwent a breast augmentation primary with a mentor memoryshape breast implant 440cc and experienced rupture on the left side post-operatively, which was confirmed via mri/mammogram.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On oct 21, 2022, additional information was received indicating the date of implantation was (b)(6) 2014.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On jun 2, 2023, additional information was received indicating the date of explantation is on (b)(6) 2023.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.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13619575
• Report Number: 1645337-2022-02078
• Device Sequence Number: 11854426
• Product Code: FTR
• UDI-Device Identifier: 00081317005490
• UDI-Public: 00081317005490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 08/31/2018
• Device Model Number: 3541408
• Device Catalogue Number: 3541408
• Device Lot Number: 6750472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 06/02/2023
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 11/10/2022; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2013
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic