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

Model Number	3542513
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2019
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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast reconstruction primary with a saline mentor siltex contour profile spectrum 450cc breast implant and experienced deflation on the left side.As a result, the patient underwent removal and replacement with a mentor memoryshape breast implant 440cc, catalog number 3341252, serial number (b)(4) on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2020, 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
Device evaluation summary: during visual evaluation of the sample, a tear measuring approximately 1.5 cm within a siltex cracking area was observed on the posterior view.In addition, parallel lines of shell wear were observed on the anterior view.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices resulting in a tear at a later date.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.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 9521927
• Report Number: 1645337-2019-26173
• Device Sequence Number: 492157
• Product Code: FWM
• UDI-Device Identifier: 00081317002154
• UDI-Public: 00081317002154
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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: 07/19/2009
• Device Model Number: 3542513
• Device Catalogue Number: 3542513
• Device Lot Number: 5620051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 02/17/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/29/2020; 02/18/2020
• 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: 84 YR