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

Model Number	3542480M
Medical Device Problem Codes	Material Rupture (1546); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2016
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.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: unknown.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 475cc mentor siltex round spectrum prosthesis (left) and experienced an unspecified issue postoperatively.As a result, the patient underwent removal and replacement with an unspecified breast implant on (b)(6) 2021.At this time of report, it is unknown what kind of issue that the patient experienced and resulted in the revision surgery.Follow-up is still in progress.If additional information is received in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
On 29-apr-2021, it was found that additional information regarding the patient's information and procedure was omitted on the previous report.On 30-apr-2021, mentor received additional information regarding the patient¿s information.The patient¿s race is caucasian.The relevant fields have been updated.Manufacturer's reference number: (b)(4) on 23-apr-2021, mentor received additional information regarding the patient's information and procedure.The patient's dob is (b)(6) 1939.The patient underwent a revision breast reconstruction with the reported medical device.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor received additional information regarding the patient¿s information and suspected medical device.The patient identifier is (b)(6).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.On (b)(6) 2021, mentor received additional information regarding the patient's symptoms and replacement device.The patient experienced left-sided deflation.The diagnosis was confirmed by a healthcare professional.Updated reason for device explant and/or reoperation: deflation.The replacement device is a 425cc mentor memorygel breast implant (catalog #: 3504251bc, serial #: (b)(6).Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the investigation on the suspected medical device was completed.The product was returned to mentor for evaluation with approximately 17 cm of tubing attached to the implant; the connector and injection dome were returned too.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed that the breast implant had an area of siltex cracking on the posterior view.Additionally, a tear was noted within the siltex cracking, measuring approximately 0.1 cm.Also, the shell of the implants looks blue, caused by a substance name revital-ox 2x enzymatic detergent.Leak testing was performed in accordance with mentor procedures, and no additional leak sites were detected during the analysis.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.As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the implants other than sterile saline for injection since this could compromise the product integrity.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
• MDR Report Key: 11579214
• Report Number: 1645337-2021-03222
• Device Sequence Number: 17024411
• Product Code: FWM
• UDI-Device Identifier: 00081317002123
• UDI-Public: 00081317002123
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 03/03/2021

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: 11/19/2018
• Device Model Number: 3542480M
• Device Catalogue Number: 3542480M
• Device Lot Number: 6881308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 04/29/2021; 09/01/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/29/2021; 05/22/2021; 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR