MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MX-410520
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	12/06/2021
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.The events of capsular contracture, and seroma are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.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, seroma and capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported left side "exchange from textured to smooth due to the patient concern with the product" as well as seroma, rupture and capsular contracture baker grade iii healthcare professional additionally reported "evacuation hematoma." device has been explanted.
Event or Problem Description
Healthcare professional reported left side "exchange from textured to smooth due to the patient concern with the product" as well as seroma, rupture and capsular contracture baker grade iii.Healthcare professional additionally reported "evacuation hematoma." device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: weight to the spec and two openings on anterior.A microscopic analysis was performed which identified: two striated openings on anterior.Based on the device analysis the final assessment is: two striated openings on anterior assessed as surgical damage.

• Brand Name: STYLE 410 COHESIVE 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: 13231055
• Report Number: 9617229-2021-59756
• Device Sequence Number: 19807601
• Product Code: FTR
• UDI-Device Identifier: 10888628003767
• UDI-Public: 10888628003767
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 09/07/2021
• Device Model Number: MX-410520
• Device Catalogue Number: MX-410520
• Device Lot Number: 2969705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• 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: 55 YR
• Patient Sex: Female