MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA X-FULL 560CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	SSZ-X560
Medical Device Problem Codes	Off-Label Use (1494); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: capsular contracture grade iii.The reported events are physiological complications, and device analysis typically does not help allergan determine the cause.
Event or Problem Description
Healthcare professional reported via national breast implant registry (nbir) manufacturer registry specific data report (mrsdr) capsular contracture grade iii.This record is for the left side.Device was replaced.
Additional Manufacturer Narrative
Upon further review, the event of left side capsular contracture grade iii is the device which was replaced by the sizer on record and has been reported via g8 mfr.Report # 9617229-2026-06040.
Event or Problem Description
Healthcare professional reported via national breast implant registry (nbir) manufacturer registry specific data report (mrsdr) "patient implanted with sizer".This record is for the right side.Device is implanted.

• Brand Name: NATRELLE INSPIRA X-FULL 560CC SSZ US
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24777379
• Report Number: 9617229-2026-06016
• Device Sequence Number: 6133795
• Product Code: MRD
• UDI-Device Identifier: 10888628045910
• UDI-Public: (01)10888628045910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: SSZ-X560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/09/2026
• 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: Unknown