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

Model Number	120-260
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	10/14/2021
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 right side rupture.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: underweight and broken shell.A visual and microscopic analysis was performed which identified: striated broken on anterior.Based on the device analysis the final assessment is: a striated broken on anterior side assessed as surgical damage.
Event or Problem Description
Physician reported "replacement due to rupture in right side" confirmed via ultrasound."bilateral breast pain and tighten sensation for a month" was reported via clinical chart."rt periprosthetic fluid collection," "r/o prosthetics injury," and "breast pain" were also reported via sonogram.The device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Physician reported "replacement due to rupture in right side" confirmed via ultrasound."bilateral breast pain and tighten sensation for a month" was reported via clinical chart."rt periprosthetic fluid collection," "r/o prosthetics injury," and "breast pain" were also reported via sonogram.The 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: 13239920
• Report Number: 9617229-2022-00005
• Device Sequence Number: 17281839
• Product Code: FTR
• UDI-Device Identifier: 10888628002524
• UDI-Public: 10888628002524
• 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: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2022

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: 06/26/2021
• Device Model Number: 120-260
• Device Catalogue Number: 120-260
• Device Lot Number: 2942100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 04/27/2022; 06/06/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2016
• 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
• Patient Weight: 54 KG