MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast reconstruction surgery with implantation of a 525cc mentor smooth round spectrum saline prosthesis.Post-operatively, the patient had an in-office visit with their health professional who utilized magnetic resonance imaging to diagnose a deflated right breast prosthesis.As a result, the patient underwent removal and replacement with a 525cc mentor smooth round spectrum saline prosthesis on (b)(6) 2022.
Additional Manufacturer Narrative
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 (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: deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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 (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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast reconstruction surgery with implantation of a 525cc mentor smooth round spectrum saline prosthesis.Post-operatively, the patient had an in-office visit with their health professional who utilized magnetic resonance imaging to diagnose a deflated right breast prosthesis.As a result, the patient underwent removal and replacement with a 525cc mentor smooth round spectrum saline prosthesis on (b)(6) 2022.
Additional Manufacturer Narrative
On march 08, 2022, the mentor analysis lab received the suspect medical device for evaluation.An evaluation was completed on april 04, 2022.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that an area of delamination was observed at the union between the patch and shell, causing leakage on the breast implant.Leak testing was performed, in accordance with mentor procedures, and no more leak sites were detected during the analysis.Although potential causes of patch delamination are unknown, stresses and forces on the implant in-vivo or exposure to betadine at insertion could result in delamination and ruptures.Per the current product insert data sheet (pids), deflation is a known complication associated with these devices and can occur at any time during or after implantation.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 13388832
• Report Number: 1645337-2022-00975
• Device Sequence Number: 16578872
• Product Code: FWM
• UDI-Device Identifier: 00081317002031
• UDI-Public: 00081317002031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2008
• Device Model Number: 3501485
• Device Catalogue Number: 3501485
• Device Lot Number: 5571131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2004
• 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: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White