MAUDE Adverse Event Report: MENTOR MEDICAL SYSTEM B.V. MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341355
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
Event or Problem Description
It was reported that a female patient underwent an unspecified breast surgery with a mentor memoryshape breast implant 475cc gel breast prosthesis that ruptured post implantation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
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).
Additional Manufacturer Narrative
On 08-jun-2022, the mentor failure analysis lab received the device for evaluation.The suspect medical device is catalog #334-1355, lot #6429789.An explantation date was not reported.Reason for device explant and/or reoperation: breast prosthesis rupture.Lot #6429789 was manufactured in mentor¿s leiden manufacturing facility.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.No additional reports will be submitted for this event as mdr reports are not required for this device.G1.Manufacturer contact phone number: (b)(6).G1.Manufacturer site fax: (b)(6).G1.Manufacturer site phone: (b)(6).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• 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: maikel ruijgers ; zernikedreef 2; leiden, TX 2333 -CL ; NL 2333 CL ; 6465917981
• MDR Report Key: 14271560
• Report Number: 1645337-2022-04937
• Device Sequence Number: 5702886
• Product Code: FTR
• UDI-Device Identifier: 00081317005353
• UDI-Public: 00081317005353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 3341355
• Device Catalogue Number: 334-1355
• Device Lot Number: 6429789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2010
• 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; Required Intervention
• Patient Sex: Female