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

Catalog Number	68HP-600
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported via national breast implant registry (nbir) manufacturer registry specific data report (mrsdr) "device migration/implant malposition".This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
The events of migration and malposition are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: migration, malposition.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 25384360
• Report Number: 9617229-2026-10385
• Device Sequence Number: 16039326
• Product Code: FWM
• UDI-Device Identifier: 10888628000469
• UDI-Public: (01)10888628000469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68HP-600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 06/03/2026
• 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 Sex: Female
• Patient Weight: 60 KG