MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported "rupture".This record is for the left side.Device remains implanted.
Event or Problem Description
Healthcare professional reported "rupture".This record is for the left side.Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h.3., h.6.Device evaluation based on the device analysis grid, the assessments of the complaint are: rupture : observed, opening side assessed as unidentified (tear) opening.(shell thickness was within specification).No additional observation.
Additional Manufacturer Narrative
Clarification to d.9.Returned to mfg on: the device has not been returned.Photo evaluation: visual analysis of the photographs identified: ¿ rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.No additional observations were carried out.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Device has been explanted and replaced.

• Brand Name: STYLE 120 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: 17644781
• Report Number: 9617229-2023-14220
• Device Sequence Number: 12746900
• Product Code: FTR
• UDI-Device Identifier: 10888628002555
• UDI-Public: 10888628002555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2023

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: 02/10/2020
• Device Catalogue Number: 120-400
• Device Lot Number: 2713066
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 11/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/02/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2015
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 55 KG