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

Model Number	3542514
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/12/2020
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.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 (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female who underwent breast reconstruction primary with a 550 cc mentor siltex contour profile spectrum, saline breast implant experienced right sided deflation post procedure.The deflation was diagnosed by a physician.As a result, the device was explanted on (b)(6) 2020.
Additional Manufacturer Narrative
Suspect device was received on (b)(6) 2020.Information received with the device indicated that the patient underwent replacement with an unknown device on (b)(6) 2020.Device evaluation completed on (b)(6) 2020: during the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the anterior view measuring approximately less than 0.1 cm.Please note that the product evaluation lab couldn´t identify a conclusion due to the specific nature of this rupture and insufficient paperwork.The evaluation was limited to non-destructive testing.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated device evaluation completed on january 25, 2021: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak test and microscopic examination of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the spec siltex contour 550cc returned device.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the anterior view measuring approximately less than 0.1 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.It should be noted that product failure is multifactorial.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10786244
• Report Number: 1645337-2020-14082
• Device Sequence Number: 3644504
• Product Code: FWM
• UDI-Device Identifier: 00081317002161
• UDI-Public: 00081317002161
• 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: 2019
• 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
• Report Date (Section B): 10/12/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 3542514
• Device Catalogue Number: 3542514
• Device Lot Number: 7632975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 01/25/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/09/2020; 01/27/2021
• 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: 66 YR