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

Model Number	110-330
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
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 "textured implants." additionally, healthcare professional reports "breast implants demonstrate internal capsular rupture¿.Healthcare professional additionally reports "abdominal pain".Device has been explanted.
Event or Problem Description
Healthcare professional also reported "abdominal pain"; this is not device related.Additionally, healthcare professional reported capsular contracture, baker grade iii.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified encapsulation, red particles in the shell, brown particles in the shell, green mold (approx.10%) in the shell, deformation, and cloudiness in the gel observed after autoclave disinfection cycle.Weight measurement of the device identified device was underweight.Device was reweighed on mo 502-65-004 and identified device weight was within specification.Based on the device analysis the final assessment was device was not ruptured.Additional, changed, and/or corrected data: b.5., b.6., b.7., d.6b., d.9., h.3., h.6.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: rupture and capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported left side "textured implants." additionally, healthcare professional reports "breast implants demonstrate internal capsular rupture¿.Healthcare professional additionally reports "abdominal pain"; this is not device related.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: 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: 11010547
• Report Number: 9617229-2020-21677
• Device Sequence Number: 753409
• Product Code: FTR
• UDI-Device Identifier: 10888628002234
• UDI-Public: 10888628002234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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: 05/11/2020
• Device Model Number: 110-330
• Device Catalogue Number: 110-330
• Device Lot Number: 2753427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 01/26/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/10/2021
• 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