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

Model Number	10-420
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2020
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.
Event or Problem Description
Patient reported "right side rupture".Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., d.6b., h.6.
Event or Problem Description
Patient reported "right side rupture".Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: around 0-25% of the shell is missing, fold creases and underweight.A microscopic analysis was performed which identified: broken shell with striated edge on radius side assessed as surgical damage and broken shell with sharp edge on posterior side in the same location of crease assessed as fold flaw opening, stress marks.Based on the device analysis the final assessment is: broken shell with striated edge on posterior side assessed as surgical damage consistent in the use of some surgical tool.Broken shell with smooth edge on posterior side in the same location of crease assessed as fold flaw opening.Missing shell due to inconclusive.

• 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; CS
• MDR Report Key: 10987684
• Report Number: 9617229-2020-20473
• Device Sequence Number: 3562291
• Product Code: FTR
• UDI-Device Identifier: 10888628001282
• UDI-Public: 10888628001282
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2021

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: 10-420
• Device Catalogue Number: 10-420
• Device Lot Number: 2663934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 03/10/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/04/2021; 04/08/2021
• 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: 57 YR