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

Model Number	MX-410520
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/01/2019
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.The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 and infection.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported right side "concern with the textured implants." patient additionally reported right side rupture and infection.Device has been explanted.
Event or Problem Description
Patient reported right side "concern with the textured implants." patient additionally reported right side rupture and infection.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation findings: environmental monitoring results for november 2015 were reviewed and all results were found acceptable.Bioburden testing results for the november 2015 were found to be acceptable.The review of the sterilization records demonstrated acceptable results therefore no training revision was required for this process.The complaint listing report indicates that there were no other records related to this event for units manufactured on work order 2830411 and sterilized under sterilization run 30021342.With the information collected during the investigation, there is enough evidence to support that device serial number (b)(6) was manufactured under controlled conditions in accordance with allergan procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run 30021342 not related to any additional complaint infection record reported as of today.Given the fact that the cause of the infection cannot be specifically associated to manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.

• 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
• MDR Report Key: 11504898
• Report Number: 9617229-2021-04669
• Device Sequence Number: 3996953
• Product Code: FTR
• UDI-Device Identifier: 10888628003767
• UDI-Public: 10888628003767
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 10/13/2020
• Device Model Number: MX-410520
• Device Catalogue Number: MX-410520
• Device Lot Number: 2830411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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: 60 YR