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

Model Number	10-390
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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.
Event or Problem Description
Patient reported a right side rupture.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified the device was underweight, had a broken shell, and fold creases.A visual and microscopic analysis were performed which identified a sharp crease break on the radius side, stress marks, and a missing shell.Based on the device analysis, the final assessment is a sharp crease break on the radius side assessed as a fold flaw opening and missing shell assessed as inconclusive.Additional, corrected, and/or changed data: b.5., d.6b., d.9., g.2., h.3., h.6.
Event or Problem Description
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
• MDR Report Key: 11229861
• Report Number: 9617229-2020-23124
• Device Sequence Number: 17033193
• Product Code: FTR
• UDI-Device Identifier: 10888628001275
• UDI-Public: 10888628001275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 09/17/2019
• Device Model Number: 10-390
• Device Catalogue Number: 10-390
• Device Lot Number: 2663933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: 58 YR