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

Catalog Number	3542430M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2018
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 device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant product: catalog: 3542620r lot: 174455.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent primary breast augmentation with mentor siltex round spectrum 225cc saline breast prosthesis.Deflation of the left breast prosthesis was determined.As a result, the patient underwent removal on (b)(6) 2018.
Additional Manufacturer Narrative
On 7/12/2018, mentor became aware that the correct concomitant product was mentor siltex round moderate profile 175cc saline catalog: 3542620 lot: 174455.Mentor also became aware that the replacement devices were the following: (left) mentor memorygel breast implant 300cc gel catalog: 3503004bc, lot: 7466044, sn: (b)(4) and (right) mentor memorygel breast implant 325cc gel catalog: 3503254bc, lot: 7442440, sn: (b)(4).On 7/13/2018, a device history record review was performed for the complaint device.As a result, the manufacturing date and expiration date fields have been updated.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 7/16/2018, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Upon receipt by mentor, the device returned without fluid.Brown material was observed within the device.No foreign material was observed on the shell surface.Product evaluation discovered a rent measuring approximately 0.6 cm within lines of shell wear and area of siltex cracking on the posterior aspect, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.There is no evidence that the issue is related with manufacturing.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds (i.E., severe ¿v¿ or tight folds) in the rtv shell of siltex breast implants.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.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: 7570622
• Report Number: 1645337-2018-03477
• Device Sequence Number: 2364662
• Product Code: FWM
• UDI-Device Identifier: 00081317002079
• UDI-Public: 00081317002079
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/16/2018

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 Catalogue Number: 3542430M
• Device Lot Number: 169252R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 05/16/2018; 08/14/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/13/2018; 08/06/2018; 08/15/2018
• 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: 34 YR