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

Model Number	MM-410320
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: rupture, "has textured implant which she wants to be removed, gross looking with a hard lump, shape of the breast is like a goard sitting on chest and spills out bras.".
Event or Problem Description
Patient reported "has textured implant which she wants to be removed, gross looking with a hard lump, shape of the breast is like a goard sitting on chest and spills out bras," and "breast actually swelled up and burst." this record is for the right side.Device remains implanted.
Event or Problem Description
Patient additionally reported "capsular contracture baker grade iv and hardening." device has been explanted.
Event or Problem Description
Patient also reported bilateral numbness.Healthcare professional reported right side capsular contracture, baker grade "iii/iv".Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported "double capsule." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified; deformation, fold creases, wear abrasion, weight within specification.After autoclave cycle was identified: cloudy gel.Based on the device analysis the final assessment is: no issues found related to the manufacturing process.

• 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; CS
• MDR Report Key: 10860991
• Report Number: 9617229-2020-18935
• Device Sequence Number: 3803084
• Product Code: FTR
• UDI-Device Identifier: 10888628003637
• UDI-Public: 10888628003637
• Combination Product (Y/N): N
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2021

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: 02/11/2020
• Device Model Number: MM-410320
• Device Catalogue Number: MM-410320
• Device Lot Number: 2716433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/19/2021; 04/08/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/13/2021; 02/16/2021; 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR