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

Model Number	3542640
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: left breast prosthesis deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient underwent a primary breast augmentation procedure with an unspecified mentor smooth saline breast prosthesis that deflated after implantation.Deflation of the patient¿s left breast prosthesis was confirmed by a physician¿s physical examination.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On 14-apr-2020, mentor received additional information about the event.It was initially reported that the patient underwent explantation on (b)(6) 2020.New information states that the patient will undergo explantation on (b)(6) 2020.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 08-jun-2020, mentor received additional information about the event.It was initially reported that the explantation date is (b)(6) 2020.New information states that the explantation date is (b)(6) 2020.The patient had both of her breast prostheses removed and they were replaced with mentor smooth round moderate plus profile 375cc saline breast prostheses.Manufacturer¿s reference number:(b)(4).
Additional Manufacturer Narrative
On 24-mar-2022, mentor received additional information about the event.It was previously reported that the suspect medical device is an unspecified mentor smooth saline breast prosthesis.New information received states that the device is a mentor siltex round moderate profile 275cc saline breast prosthesis.On 28-mar-2022, 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
It was previously reported that the suspect medical device is a mentor siltex round moderate profile 275cc saline breast prosthesis, catalog #3542640.On 13-apr-2022, it was determined that the correct catalog number is 3542440m.The suspect medical device is a mentor siltex round spectrum 275cc saline breast prosthesis.On 25-apr-2022, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the breast implant.The product was returned to mentor for evaluation.The tubing, the connector, and the injection port were not received.Mentor conducted a 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 breast implant.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the posterior view within the siltex cracking, measuring approximately 0.1 cm.The evaluation determined that the cause of the deflation is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.A second product was received.No adverse events were reported for this concomitant (contralateral) device.Therefore, no further analysis is required.It should be noted that as part of the mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX 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 ; 949789-8687
• MDR Report Key: 9941836
• Report Number: 1645337-2020-05480
• Device Sequence Number: 2077168
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1992
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/19/2020

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 Model Number: 3542640
• Device Catalogue Number: 3542440M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 06/08/2020; 03/24/2022; 04/13/2022
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/05/2020; 06/16/2020; 04/05/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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