MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	168-270
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Facility name: hospital.A review of the device history record has been completed.No deviations or non-conformance's noted.Device evaluation: visual analysis of the returned device identified: opening and yellow particles.Leak test was performed and found opening on the device.A microscopic analysis was performed which identify a striated edge opening, consist with use of a surgical tool and have non-penetrating nick striated.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a striated edge opening on anterior side due to surgical damage.Non-penetrating nick striated.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: capsular contracture, baker grade unknown.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to (b)(4) has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Healthcare professional reported left side exchange of biocell textured.Implants due to the patient's concern with the product.Additionally hcp reported capsular contracture baker grade unknown and "bottoming out of the breast." device has been explanted.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11580177
• Report Number: 9617229-2020-21286
• Device Sequence Number: 19900143
• Product Code: FWM
• UDI-Device Identifier: 10888628000803
• UDI-Public: 10888628000803
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2021

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: 12/07/2019
• Device Model Number: 168-270
• Device Catalogue Number: 168-270
• Device Lot Number: 2852825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 03/27/2021
• 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