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

Model Number	MF-410640
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In response to fda report number: mw5101297.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.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 left side rupture.The device remains implanted.
Event or Problem Description
Healthcare professional reported a rupture.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening, underweight, crease fold, wear abrasion.A microscopic analysis was performed which identify a sharp edge opening assessed as unidentified tear opening.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp opening on posterior assessed as unidentified (tear) opening.

• 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: 12052057
• Report Number: 9617229-2021-46293
• Device Sequence Number: 17249417
• Product Code: FTR
• UDI-Device Identifier: 10888628003521
• UDI-Public: 10888628003521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 07/13/2020
• Device Model Number: MF-410640
• Device Catalogue Number: MF-410640
• Device Lot Number: 2791239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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: 74 YR