MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 10 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	10-550
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Handling Problem (3265)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: capsular contracture baker grade iii/iv.
Event or Problem Description
Patient reported left side capsular contracture possible baker grade iii/iv, really hard, tightening, when touches bottom of breast feels ripples and is not smooth, opened, big knots, feels a fold, feels like something that's not supposed to be there, scar tissue.Device remains implanted.
Event or Problem Description
Healthcare professional, additionally reported, capsular contracture, baker grade iii/iv.But it was "nicked", during explant surgery.So, there is a small puncture.Healthcare professional, also reported, rupture.That is not device related.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe since it is not related to the device.Visibility/palpability: unable to observe since it is not related to the device.Lump/nodule: unable to observe since it is not related to the device.Crease/folding of implant and wrinkling: crease fold observed on the device.Use error: observed an opening on anterior assessed as fold flaw opening.Rupture-ndr: not applicable as the event is not related to the device.Additional observations: stress marks and wear abrasion observed on the device.Brown particles observed on the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported left side "capsular contracture possible baker grade iii/iv, really hard, tightening, when touches bottom of breast feels ripples and is not smooth, opened, big knots, feels a fold, feels like something that's not supposed to be there, scar tissue".Later, healthcare professional reported left side capsular contracture baker grade iii/iv and the following events that are not device related: "but it was "nicked" during explant surgery, so there is a small puncture" and "punctured when removed".Healthcare professional also reported rupture that is not device related.Device has been explanted.

• Brand Name: STYLE 10 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: 17121260
• Report Number: 9617229-2023-09806
• Device Sequence Number: 15115812
• Product Code: FTR
• UDI-Device Identifier: 10888628001329
• UDI-Public: 10888628001329
• Combination Product (Y/N): N
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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: 09/16/2019
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Device Lot Number: 2663938
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 09/13/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/08/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2014
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 82 KG