MAUDE Adverse Event Report: MENTOR MEDICAL SYSTEM B.V. SILTEX ULTRA HIGH PROFILE; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3545320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/11/2021
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: as of now there is no information regarding the explant or reoperation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent unspecified breast surgery with 320cc mentor memorygel breast implant on both sides and experienced bilateral capsular contracture; baker grade unknown.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On march 3, 2022, mentor received lot number information of the impacted device.The lot number indicated that the device in this complaint was manufactured in leiden, netherlands.Mentor medical systems b.V, located in leiden, the netherlands, is a foreign manufacturer of medical devices that are not cleared or approved for sale in the us.It is a separate legal entity from mentor texas.Per 21 cfr 803.58 and "medical device reporting for manufacturers" (fda guidance document issued on november 8, 2016), we are ¿[not] required to submit mdr reports for events occurring in other countries for a device that is manufactured in a foreign country and that is not cleared or approved for marketing in the us.However, if [mentor becomes] aware of information that reasonably suggests a device has malfunctioned and that a similar device that [is] marketed in the us would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, then [mentor] should report the device malfunction that occurred outside the us." since mentor medical systems b.V.Do not market any devices in the us, manufacture & market all their devices outside the us, and have never held fda approval nor clearance for any of their products, their devices do not meet the criteria for mdr reportability.Hence, no further reporting on this event is required.The information has been updated on this form.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: SILTEX ULTRA HIGH PROFILE
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR MEDICAL SYSTEM B.V.; zernikedreef 2; leiden TX 2333 CL; NL 2333 CL
• Manufacturer (Section G): MENTOR TEXAS; zernikedreef 2; leiden TX 2333 CL; NL 2333 CL
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13619724
• Report Number: 1645337-2022-02081
• Device Sequence Number: 4725705
• Product Code: FTR
• UDI-Device Identifier: 00081317007111
• UDI-Public: 00081317007111
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 3545320
• Device Catalogue Number: 354-5320
• Device Lot Number: 5944991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female