MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	115-203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 reported unknown side "rupture".Device remains implanted.
Event or Problem Description
Patient reported, left side "rupture".Healthcare professional later reported, "biocell replacement".Device was explanted.
Additional Manufacturer Narrative
Device evaluation:analysis of the returned device identified: underweight, broken shell and missing shell.A visual and microscopic analysis was performed which identified: striated opening on posterior and broken striated on posterior.Based on the device analysis the final assessment is: missing shell assessed as inconclusive a striated opening on posterior assessed as surgical damage.
Event or Problem Description
Patient reported left side "rupture." healthcare professional later reported "biocell replacement." device was explanted.

• Brand Name: STYLE 115 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: 12601933
• Report Number: 9617229-2021-54750
• Device Sequence Number: 11617988
• Product Code: FTR
• UDI-Device Identifier: 10888628002333
• UDI-Public: 10888628002333
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2022

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: 03/25/2020
• Device Model Number: 115-203
• Device Catalogue Number: 115-203
• Device Lot Number: 2731642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 06/08/2022
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 03/29/2022; 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2015
• 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: 43 YR
• Patient Sex: Female