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

Model Number	3542620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2021
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: right deflation.(b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent unspecified breast surgery with 175cc mentor siltex round moderate profile on both sides on (b)(6) 1995, and experienced bilateral breast implant deflation postoperatively.As a result, the devices were explanted on (b)(6) 2021.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the patient was not a carrier of a saline prosthesis, the reference of her devices are: mentor catalog number 354-2007, right breast l26291 left breast l26291.The device were manufactured in the mentor leiden facility in the netherlands.The mentor leiden breast implants that are manufactured and distributed under the mentor brand but are not approved for import into the united states do not appear to 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.However, as this event was already reported, mentor will send this last follow-up report and no further supplemental reports will be submitted thereafter.The corresponding fields have been correctly updated on this form.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR MEDICAL SYSTEM B.V.; zernikedreef 2; leiden TX 2333 CL; NL 2333 CL
• MDR Report Key: 11938831
• Report Number: 1645337-2021-06269
• Device Sequence Number: 4227083
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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 Model Number: 3542620
• Device Catalogue Number: 354-2007
• Device Lot Number: L26291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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