MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SCM-755
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "exposed rupture".Device will not be returned.This record is for the right side.Device has been explanted.
Additional Manufacturer Narrative
Correction to b5 description of event and h6 adverse event problem in the initial medwatch: the initial report stated "exposed rupture" and reported a0412 material rupture, a0101 patient-device incompatibility, and e2316 foreign body reaction in error.Healthcare professional only reported "exposed implant" and indicated it was not device-related.Abbvie medical safety has determined this event is not device-related, and it will be un-reported.Additional, changed, and/or corrected data: b2, b5, h6, h11.
Event or Problem Description
Healthcare professional reported right side "exposed implant" and indicated it is not related to the device.Device has been explanted and replaced.
Additional Manufacturer Narrative
The event of exposure is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: exposure, rupture.A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 21883964
• Report Number: 9617229-2025-06612
• Device Sequence Number: 8097647
• Product Code: FTR
• UDI-Device Identifier: 10888628030008
• UDI-Public: (01)10888628030008(10)3675140(11)230213(17)280113
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: SCM-755
• Device Lot Number: 3675140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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