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

Model Number	68LP-525
Medical Device Problem Codes	Material Rupture (1546); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Healthcare professional reported right side rupture.Device remains implanted.
Event or Problem Description
Additionally, ¿no.68 low profiles 525cc filled to 400cc previously¿ was reported.The device was explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified fold creases, wear abrasion, one extended opening and yellow particles in device inner surface.A microscopic analysis and leak test were performed which identified one opening crease smooth.Fill inspection was performed and identified no blockage in the valve.Based on the device analysis the final assessment is: one opening crease smooth in the side anterior assessed as fold flaw opening.Additional, changed, and/or corrected data.
Event or Problem Description
Healthcare professional reported "right side rupture." later, healthcare reported "filled to 400cc (for a 575 implant)" and "any creases." the device has been explanted and replaced.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 14311578
• Report Number: 9617229-2022-07336
• Device Sequence Number: 14780786
• Product Code: FWM
• UDI-Device Identifier: 10888628000650
• UDI-Public: 10888628000650
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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 Model Number: 68LP-525
• Device Catalogue Number: 68LP-525
• Device Lot Number: 3044185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 06/17/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/09/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 86 KG