MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-185
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6.Health effect - impact code continued: f2201 - biopsy, f2203 - imaging required.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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, calcification, lump/nodule-ndr.
Event or Problem Description
Patient reported right side "rupture," ¿left 9 o'clock direction 3 cm: 6.1x3.8 mm positive lime copper low-shaded nodule,¿ and "calcification." the event of ¿left 9 o'clock direction 3 cm: 6.1x3.8 mm positive lime copper low-shaded nodule¿ is not device related.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device photo analysis : visual analysis of the photographs identified: rupture: observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.Calcification : no observed on the device.Lump/nodule : not applicable as the event is not related to the device.No additional observations.No further actions are required since no issue in the manufacturing of the device is observed.
Event or Problem Description
Patient reported right side "rupture," ¿left 9 o'clock direction 3 cm: 6.1x3.8 mm positive lime copper low-shaded nodule,¿ and "calcification." the event of ¿left 9 o'clock direction 3 cm: 6.1x3.8 mm positive lime copper low-shaded nodule¿ is not device related.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, opening device on radius side assessed, as surgical impact opening (shell thickness was within specification).Lump/nodule-ndr: not applicable, as the event is not related to the device.Calcification: not observed.Additional observations: stress marks observed, crease fold observed, yellow particles on the surface of the shell, wear abrasion observed.No further actions are required, as the device was implanted.
Event or Problem Description
Patient reported, right rupture.Device has been explanted.

• Brand Name: STYLE 115 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: 17632221
• Report Number: 9617229-2023-14147
• Device Sequence Number: 15364840
• Product Code: FTR
• UDI-Device Identifier: 10888628002326
• UDI-Public: 10888628002326
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

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: 01/09/2021
• Device Catalogue Number: 115-185
• Device Lot Number: 2868764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 10/10/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2016
• 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: 61 YR
• Patient Sex: Female