MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FX-410410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported rupture.The device remains implanted.This relates to the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture.
Event or Problem Description
Patient's spouse reported left side "silicone in lymph nodes".Healthcare professional later reported left side "tear of shell" and "signs of gel fracture".Device has been explanted and replaced.
Additional Manufacturer Narrative
The event of "lymphadenopathy" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional reported rupture.This relates to the left side.Patient's spouse reported left side "silicone in lymph nodes".Healthcare professional later reported left side "tear of shell" and "signs of gel fracture".Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ anxiety-product/procedure: unable to observe as it is not related to the device.¿ rupture: one opening on anterior side assessed as surgical damage ¿ lymphadenopathy: unable to observe as it is not related to the device.Additional observations: ¿ encapsulation observed.¿ creases were observed.¿ black mold like appearance observed.¿ nick striated observed assessed as surgical tool scratch like.No further actions are required as no manufacturing issues are observed.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17255369
• Report Number: 9617229-2023-10852
• Device Sequence Number: 5910553
• Product Code: FTR
• UDI-Device Identifier: 10888628002982
• UDI-Public: 10888628002982
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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: 01/11/2020
• Device Model Number: FX-410410
• Device Catalogue Number: FX-410410
• Device Lot Number: 2697176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 10/20/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/29/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2015
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG