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

Model Number	SSLP-440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 left side "rupture." device remains implanted.
Event or Problem Description
Healthcare professional additionally reported "any creases," no obvious hole," and "seemed to be a small ant on outside shell." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: no observed openings during analysis.¿ crease/folding of implant: observed creases on the device.Additional observations: ¿ observed wear abrasion on the device.¿ observed deformation on the device.¿ split in patch area due to a workmanship.A further investigation is requested to review the workmanship observed.Further investigation results: according to the device analysis performed in the laboratory, it was observed split in patch area, it is out of specification per qa 199.04 (ss).According to the analysis review the event rupture was not observed, and it was observed the event of crease/folding of implant, however, it does not have relationship with the workmanship.A review of the current risk documents pfmea-silicone filled bi and sizer assy rev.6.0 was performed, and the event of split in patch is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with split in patch will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported a left side "deflation".Event captured as rupture as device is silicone.Healthcare professional reported later reported "any creases".Device has been explanted.

• 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: 17245594
• Report Number: 9617229-2023-10778
• Device Sequence Number: 17852523
• Product Code: FTR
• UDI-Device Identifier: 10888628032781
• UDI-Public: 10888628032781
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2023

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: 03/26/2022
• Device Model Number: SSLP-440
• Device Catalogue Number: SSLP-440
• Device Lot Number: 3047542
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 08/18/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/28/2023; 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2017
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 70 KG