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

Model Number	SMPX685
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient, who's undergone breast reconstruction with a 685cc mentor memorygel breast implant on the right breast, suffered implant exposure, dehiscence, post-procedure.The complication was diagnosed during a physical examination.As a result, the patient underwent implant removal on (b)(6) 2021.
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.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: device extrusion.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.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: device extrusion.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient, who's undergone breast reconstruction with a 685cc mentor memorygel breast implant on the right breast, suffered implant exposure, dehiscence, post-procedure.The complication was diagnosed during a physical examination.As a result, the patient underwent implant removal on (b)(6) 2021.
Additional Manufacturer Narrative
Two devices of the same lot were received with no indication which device belonged to the right breast, so both devices were analyzed.(device 1) on (b)(6) 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the smooth mod + prof xtra 685cc returned device.Extrusion may occur when the wound has not closed or when tissue covering the implants weakens.The incidence of extrusion has been shown to increase when undue pressure is applied on the tissue located over the device, trauma to surrounding tissues may lead to thrombosis, delayed wound healing, improper size, placement, larger sized implants, use of steroids in the surgical pocket and microwave diathermy.Radiation therapy has been reported to increase the likelihood of extrusion.Extrusion may require additional surgery and possible removal of the implant, which may result in additional scarring and/or loss of breast tissue.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.(device 2) on (b)(6) 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the smooth mod + prof xtra 685cc returned device.Extrusion may occur when the wound has not closed or when tissue covering the implants weakens.The incidence of extrusion has been shown to increase when undue pressure is applied on the tissue located over the device, trauma to surrounding tissues may lead to thrombosis, delayed wound healing, improper size, placement, larger sized implants, use of steroids in the surgical pocket and microwave diathermy.Radiation therapy has been reported to increase the likelihood of extrusion.Extrusion may require additional surgery and possible removal of the implant, which may result in additional scarring and/or loss of breast tissue.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• 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
• 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: 13338512
• Report Number: 1645337-2022-00725
• Device Sequence Number: 4090462
• Product Code: FTR
• UDI-Device Identifier: 00081317025160
• UDI-Public: 00081317025160
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: SMPX685
• Device Catalogue Number: SMPX685
• Device Lot Number: 9437035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White