MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional reported left side "psychological anxiety" and rupture.The has been explanted.
Event or Problem Description
¿malicious neoplasms of the breast¿ were reported but not considered device related.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of anxiety-product/procedure, rupture and cancer breast-ndr was received on (b)(6) 2020 with lot number 3016537.Visual analysis of the returned device identified: underweight, opening curved, crease fold.A microscopic analysis was performed which identify sharp edge and with non-penetrating nicks assessed as surgical impact opening and sharp edge opening in the same edge assessed as unidentified tear opening and missing piece of the shell.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: - a sharp edge opening with non-penetrating nicks due to surgical impact.-non-penetrating nicks.- a sharp opening on posterior due to an unidentified (tear) opening.-missing piece of the shell assessed as inconclusive.Additional, changed, and/or corrected data: b.5, d.10, g.1, h.3, h.6.

• Brand Name: STYLE 110 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; CS
• MDR Report Key: 9647449
• Report Number: 9617229-2020-00667
• Device Sequence Number: 2536117
• Product Code: FTR
• UDI-Device Identifier: 10888628002173
• UDI-Public: 10888628002173
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 12/30/2021
• Device Model Number: 110-150
• Device Catalogue Number: 110-150
• Device Lot Number: 3016537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR