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

Model Number	115-401
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported ¿hole, non specific¿ and patient's concern for textured implant device.Additionally reported was "greater saphenous vein insufficiency¿ which has been deemed not related to the device.The device has been explanted and replaced.
Additional Manufacturer Narrative
Postal code: (b)(6).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.Device evaluation: visual analysis of the returned device identified; underweight, curved opening, wear abrasion, fold creases.A microscopic analysis was performed which identified; a curved sharp opening on posterior side in the same location of crease.Based on the device analysis the final assessment is: a crease sharp opening assessed as fold flaw opening.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.Reason for reoperation: rupture.

• 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: 15633786
• Report Number: 9617229-2022-17004
• Device Sequence Number: 12257930
• Product Code: FTR
• UDI-Device Identifier: 10888628002418
• UDI-Public: 10888628002418
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 02/28/2020
• Device Model Number: 115-401
• Device Catalogue Number: 115-401
• Device Lot Number: 2721941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2015
• 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 Sex: Female