MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	68LP-400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2020
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: deflation.
Event or Problem Description
Healthcare professional reported ¿left side deflation and capsular contracture, baker grade ii¿.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: opening curved on anterior, creases fold and wear abrasion.Leak test and microscopic analysis was performed which identified: striated opening on anterior, opening crease sharp on posterior and observed void >1 mm in non-textured, valve-to shell-bond area.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a striated opening on anterior assessed as surgical damage consist in the use of some surgical tool and a sharp creased opening on posterior assessed as fold flaw opening.
Event or Problem Description
Device has been explanted.

• Brand Name: STYLE 68 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: 10529292
• Report Number: 9617229-2020-14711
• Device Sequence Number: 19612586
• Product Code: FWM
• UDI-Device Identifier: 10888628000612
• UDI-Public: 10888628000612
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 06/12/2021
• Device Model Number: 68LP-400
• Device Catalogue Number: 68LP-400
• Device Lot Number: 3080248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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
• Patient Age: 49 YR