MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/01/2021
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: unknown side deflation.Date of explant: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent primary breast augmentation with a 125cc mentor siltex round moderate profile and experienced unknown side breast implant deflation postoperatively diagnosed upon physical exam.As a result, the device will be explanted on (b)(6) 2021.
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 24, 2021, after multiple attempts, receipt of two 275cc devices (device received july 30, 2021) and no response, impacted product has been updated to unknown saline.All corresponding fields have been updated as well.If any additional information is received in the future, file will be updated and supplemental report will be submitted.This supplemental medwatch report is for one of the 275cc device received on july 30, 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab received the device for evaluation.Two 275cc devices were received, and the device reported is mentor siltex round moderate profile 125cc.Follow ups are in progress for clarification.Once information is received, supplemental report will be submitted.Paperwork received with the device indicated that the replacement devices used on (b)(6) 2021 were catalog number 3501645; serial number (b)(6), on the left side, and catalog number (b)(6) ; serial number (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 25, 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the saline breast implant 275cc had an area of siltex cracking on the posterior view.Additionally, a tear measuring approximately 0.8 cm was found within the siltex cracking.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.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.This supplemental medwatch report is for one of the 275cc device received on july 30, 2021.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANTS
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11966770
• Report Number: 1645337-2021-06513
• Device Sequence Number: 4354128
• Product Code: FWM
• UDI-Device Identifier: 00081317001713
• UDI-Public: 00081317001713
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• 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): 05/24/2021

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: 03/31/2003
• Device Model Number: 3542610
• Device Catalogue Number: UNK_SALINE IMPLANTS
• Device Lot Number: 190902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/14/2021; 07/30/2021; 07/30/2021; 08/25/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/15/2021; 08/20/2021; 08/24/2021; 08/25/2021
• 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: 69 YR