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

Model Number	110-390
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Seroma (2069)
Date of Event	07/05/2021
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.The events of seroma-late and granuloma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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, seroma-late, granuloma.
Event or Problem Description
Patient reported left side "rupture".Healthcare professional reported "ruptured intestinal fluid and prosthesis on both sides during the preoperative examination" and "was found to be cd30 negative in the examination conducted after collecting intestinal fluid during surgery", "many lymphocytes", "vague granuloma".Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: opening on posterior and underweight.A visual and microscopic analysis was performed which identified: sharp opening on posterior and crease fold.A dimension measurement in the shell was performed which identify the thickness within specification.Base on the device analysis the final assessment is: a sharp opening on posterior assessed as an unidentified (tear) opening.
Event or Problem Description
Patient reported left side "rupture".Healthcare professional reported "ruptured intestinal fluid and prosthesis on both sides during the preoperative examination" and "was found to be cd30 negative in the examination conducted after collecting intestinal fluid during surgery", "many lymphocytes", "vague granuloma".Device has been explanted and replaced.

• 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
• MDR Report Key: 12303615
• Report Number: 9617229-2021-49435
• Device Sequence Number: 17047168
• Product Code: FTR
• UDI-Device Identifier: 10888628002258
• UDI-Public: 10888628002258
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 04/20/2021
• Device Model Number: 110-390
• Device Catalogue Number: 110-390
• Device Lot Number: 2915370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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: 31 YR