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

Model Number	FX-410560
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
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: "patient's concern with the product" and rupture.
Event or Problem Description
Healthcare professional reported right side "patient's concern with the product." additionally, healthcare professional reported rupture.Device has been explanted.
Event or Problem Description
Healthcare professional additionally reported "any creases associated with hole.".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.4, b.5, b.6, h.3, h.6.Device evaluation: visual analysis of the returned device identified: the weight the device within specification, fold creases, deformation, and yellow particles on the shell.After autoclave cycle was observed: cloudy color in the gel.Based on the device analysis the final assessment is: creases are observed but have no relationship with manufacturing.No openings were observed on the device.

• 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: 11717413
• Report Number: 9617229-2021-06331
• Device Sequence Number: 3833541
• Product Code: FTR
• UDI-Device Identifier: 10888628003019
• UDI-Public: 10888628003019
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 11/19/2021
• Device Model Number: FX-410560
• Device Catalogue Number: FX-410560
• Device Lot Number: 3003309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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 Weight: 58