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

Model Number	120-550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: weight to the spec, deformation, wear abrasion, encapsulation (50%-100% of the area) and crease fold.Bubbles in the gel observed after autoclave cycle.Base on the device analysis the final assessment is: the unit is not rupture.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: side wall of implant pain, chronic pain¿ and ¿wanting exchange from textured to a smooth breast implant due to the patient¿s concern.
Event or Problem Description
Patient reported left side ¿side wall of implant pain, chronic pain¿ and ¿wanting exchange from textured to a smooth breast implant due to the patient¿s concern." healthcare professional additionally reported that the device was found to be ruptured.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4.
Event or Problem Description
Patient reported left side ¿side wall of implant pain, chronic pain¿ and ¿wanting exchange from textured to a smooth breast implant due to the patient¿s concern¿.Healthcare professional additionally reported that the device was found to be ruptured.Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14253035
• Report Number: 9617229-2021-55416
• Device Sequence Number: 4398002
• Product Code: FTR
• UDI-Device Identifier: 10888628002586
• UDI-Public: 10888628002586
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 08/26/2019
• Device Model Number: 120-550
• Device Catalogue Number: 120-550
• Device Lot Number: 2651396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2014
• 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
• Patient Weight: 61 KG