MAUDE Adverse Event Report: MENTOR MEDICAL SYSTEM B.V. SILTEX ULTRA HIGH PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3545295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast augmentation surgery with two 295cc mentor memorygel breast implants experienced bilateral rupture post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for breast prosthesis a.
Additional Manufacturer Narrative
In may 9, 2022, mentor became aware that patient's impacted device is a 295cc siltex ultra high profile, catalog: 3545295, lot: 6511330.The device reported in this complaint was manufactured in leiden, netherlands.The leiden breast implants that are manufactured and distributed under the mentor brand but are not approved for import into the united states do not meet the criteria for mdr reporting as a same or similar device to a device that is marketed in the united states.Specifically, the devices differ in manufacturing processes and device specifications.Therefore, events that involve these devices would not need to be reported as mdrs.No further reports would be submitted.G1.Manufacturer site fax (b)(6).G1.Manufacturer site phone (b)(6).G1.Manufacturer site zip code extension (b)(6).Manufacturer¿s reference number: (b)(4).

• Brand Name: SILTEX ULTRA HIGH PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR MEDICAL SYSTEM B.V.; zernikedreef 2; leiden TX ; NL
• Manufacturer (Section G): MENTOR TEXAS; zernikedreef 2; leiden TX ; NL
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 14191120
• Report Number: 1645337-2022-04609
• Device Sequence Number: 14099060
• Product Code: FWM
• UDI-Device Identifier: 00081317007104
• UDI-Public: 00081317007104
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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: 10/01/2016
• Device Model Number: 3545295
• Device Catalogue Number: 3545295
• Device Lot Number: 6512894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/23/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female