MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-120
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2020
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.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: rupture.
Event or Problem Description
Patient reported right side rupture."malignant neoplasm of upper-outer quadrant of right breast" and "¿cellulitis of face¿ was also reported, but considered not device related.The device has been explanted.
Event or Problem Description
Patient reported right side rupture."malignant neoplasm of upper-outer quadrant of right breast" and "¿cellulitis of face¿ was also reported, but considered not device related.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: opening extended on posterior and underweight.A visual and microscopic analysis was performed which identified: sharp opening on posterior assessed as a surgical impact opening, for the stress mark in the shell.A dimension measurement in the shell was performed which identify the thickness within specification base on the device analysis the final assessment is: a sharp opening on posterior assessed as a surgical impact opening.

• Brand Name: STYLE 110 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: 10020995
• Report Number: 9617229-2020-07213
• Device Sequence Number: 2462223
• Product Code: FTR
• UDI-Device Identifier: 10888628002166
• UDI-Public: 10888628002166
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 11/16/2020
• Device Model Number: 110-120
• Device Catalogue Number: 110-120
• Device Lot Number: 2846154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: 50 YR