UNK STYLE SCX

Report

• Report Number: 9617229-2025-18842
• Event Type: Injury
• Date Received: November 3, 2025
• Report Date: November 3, 2025
• Manufacturer: ALLERGAN (COSTA RICA)
• Product Code: FTR
• PMA / PMN Number: P020056
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

REASON FOR REOPERATION: DEVICE MIGRATION/IMPLANT MALPOSITION. THE EVENT OF "DEVICE MIGRATION/IMPLANT MALPOSITION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED ¿DEVICE MIGRATION/IMPLANT MALPOSITION¿ THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1067636	UNK STYLE SCX	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention

Terms

Patient problem · 1

• Failure of Implant

Product problems · 1

• Migration

Source type · 1

• Other

Type of report · 1

• Initial submission