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

Model Number	110-330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30 calendar days from allergan¿s receipt due to a system error preventing allergan from submitting reports via emdr.The system error has been resolved at this time and an investigation has been initiated into this occurrence.Sent in response to fda report number: mw5093057.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 via regulatory agency left side rupture.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: broken shell and others, underweight, and missing a piece of shell (25-50%).A microscopic analysis was performed which identified: one broken sharp with non-penetrating nick, near of the broken site, this condition was called surgical impact.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis the final assessment is: one sharp broken on the radius assessed as surgical impact.Missing shell due to inconclusive.
Event or Problem Description
Device has been explanted.

• 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: 9947713
• Report Number: 9617229-2020-05299
• Device Sequence Number: 3375165
• Product Code: FTR
• UDI-Device Identifier: 10888628002234
• UDI-Public: 10888628002234
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 12/22/2019
• Device Model Number: 110-330
• Device Catalogue Number: 110-330
• Device Lot Number: 2697684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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