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

Model Number	3503210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6)-year-old hispanic female patient underwent primary breast augmentation with a 210cc mentor smooth round high profile saline breast implant that deflated postoperatively, secondary to a motor vehicle accident.The deflation was confirmed during a physical exam.The patient has indicated a desire to have the device explanted and replaced with another smooth saline device, however the intervention has not yet been planned.
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: n/a.(b)(4).
Additional Manufacturer Narrative
On january 26, 2022, device evaluation was completed.Device evaluation summary: mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sm hps dv 210cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A second product was received (lot-9591675).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 17, 2022, the mentor failure analysis lab received the device for evaluation.Paperwork received with the device indicated that the date of surgery was (b)(6) 2021.Hence, following fields have been updated on this form: is required intervention has been selected under section b; field b2.Fields d6b for explantation date have been updated to december 28, 2021.Field h6 health effect - impact code ¿device explantation¿ has been added.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.Reason for device explant and/or reoperation: left deflation and chest injury manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE
• 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: 13097365
• Report Number: 1645337-2021-14273
• Device Sequence Number: 13961249
• Product Code: FWM
• UDI-Device Identifier: 00081317001584
• UDI-Public: 00081317001584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,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: 07/21/2024
• Device Model Number: 3503210
• Device Catalogue Number: 3503210
• Device Lot Number: 9483409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 01/26/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/26/2022; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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: Other; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic