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

Model Number	168-550
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
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.Device evaluation: visual analysis of the returned device identified crease flat, one curved opening on the posterior, non-penetrating nick, and yellow particles on the shell.Leak test and microscopic analysis were performed which identified one sharp edge opening on the posterior and non-penetrating nick.A dimensional measurement in the shell was performed which identified the thickness within specification.Fill test inspection was performed and the result was no blockage.Based on the device analysis the final assessment was a sharp edge opening on the posterior due to an unidentified (tear) opening, and non-penetrating nicks.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: deflation.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side deflation.Device has been explanted.
Event or Problem Description
Healthcare professional additionally reported left side capsular contracture, baker grade iii.
Additional Manufacturer Narrative
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.

• 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; CS
• MDR Report Key: 9209154
• Report Number: 9617229-2019-15392
• Device Sequence Number: 10875025
• Product Code: FWM
• UDI-Device Identifier: 10888628000896
• UDI-Public: 10888628000896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 11/02/2020
• Device Model Number: 168-550
• Device Catalogue Number: 168-550
• Device Lot Number: 2993539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/16/2020
• 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