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	01/01/2020
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 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) caucasian female patient who underwent a breast reconstruction primary with a 550cc textured mentor siltex contour profile spectrum saline breast implant has experienced postoperative right-sided deflation, confirmed by a physician.As a result, the patient underwent unilateral explantation and replacement with unspecified breast implant on (b)(6) 2020.
Additional Manufacturer Narrative
On 10-feb-2020, 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.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 10-mar-2020, per secondary review of the file, mentor became aware that the following information was omitted.The patient underwent unilateral replacement with 460cc mentor smooth round high profile saline breast implant, catalog # 3503460, right serial # (b)(6) on 23-jan-2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 10-mar-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a deflation on the breast implant.During visual inspection of the sample, an area of siltex cracking was observed on the posterior view.Additionally, a tear measuring approximately 1 cm was noted within the siltex cracking area.The evaluation determined that the rupture is consistent with the siltex cracking.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.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Breast implants are not considered lifetime devices.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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.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: 9667754
• Report Number: 1645337-2020-01860
• Device Sequence Number: 3135261
• Product Code: FWM
• UDI-Device Identifier: 00081317002161
• UDI-Public: 00081317002161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/15/2020

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: 05/02/2009
• Device Model Number: 3542514
• Device Catalogue Number: 3542514
• Device Lot Number: 5606276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 03/10/2020; 03/10/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/04/2020; 03/10/2020; 03/10/2020
• 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: 71 YR