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

Model Number	SRLP-190
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.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 a right side intracapsular rupture confirmed via mri.Device remains implanted.
Event or Problem Description
Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening, underweight.A microscopic analysis was performed which identify sharp edge and with non-penetrating nicks assessed as surgical impact opening.A dimension measurement in the shell was performed which identify the thickness within specification.Stress mark.Based on the device analysis the final assessment is: a sharp edge opening with non-penetrating nicks assessed as surgical impact.Non-penetrating nicks.Additional, changed, and/or corrected data: b5, b6, d6b, d9, h3, h6.

• Brand Name: INSPIRA SMOOTH 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
• 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: 15156350
• Report Number: 9617229-2022-12828
• Device Sequence Number: 5120143
• Product Code: FTR
• UDI-Device Identifier: 10888628006836
• UDI-Public: 10888628006836
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 Expiration Date: 09/03/2021
• Device Model Number: SRLP-190
• Device Catalogue Number: SRLP-190
• Device Lot Number: 2967204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 52 KG