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

Model Number	TRM-560
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Device evaluation: visual analysis of the returned device identified it to be underweight, a broken shell and non-penetrating nicks.A microscopic analysis was performed which identified a sharp edge with non-penetrating nicks, assessed as a surgical impact opening on the posterior side.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis the final assessment is: a sharp broken edge with non-penetrating nicks due to surgical impact.Also observed were non-penetrating nicks.The event of lymphadenopathy is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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, lymphadenopathy.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported left side "dents and wrinkling", exchange from textured to smooth implants due to the patient's concern with the product, "itching and bumps in her armpit", rupture, pain and "lopsided".Patient additionally reported "cyst and that it is nothing to do with the implants" which is not device related.Healthcare professional reported left side rupture and exchange from a textured to smooth breast implant due to the patient¿s concern with the product.Device has been explanted.

• Brand Name: INSPIRA TEXTURED 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
• MDR Report Key: 11648543
• Report Number: 9617229-2021-06483
• Device Sequence Number: 11676883
• Product Code: FTR
• UDI-Device Identifier: 10888628008175
• UDI-Public: 10888628008175
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 07/05/2020
• Device Model Number: TRM-560
• Device Catalogue Number: TRM-560
• Device Lot Number: 2784364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 04/12/2021
• 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