MAUDE Adverse Event Report: IDEAL IMPLANT IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE-FILLED BREAST IMPLANT

Model Number	63501
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant analysis determined that deflation of the outer lumen was due to a tear of the outer shell.The shell thickness was within specification and there was no evidence of shell folding or fatigue.No other defect or abnormality was noted.The cause of the shell tear is unknown.
Event or Problem Description
Deflation resulting in explantation.
Event or Problem Description
Deflation resulting in explantation.
Additional Manufacturer Narrative
Explant analysis determined that deflation of the outer lumen was due to a tear of the outer shell.The shell thickness was within specification and there was no evidence of shell folding or fatigue.No other defect or abnormality was noted.The cause of the shell tear is unknown.Update/corrections to the following sections: b4, d4, d10, g7, h2, and h10.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT
• Manufacturer (Section D): IDEAL IMPLANT; 14481 quorum drive; suite 925; dallas, 75254
• MDR Report Key: 8728932
• Report Number: 3011491947-2019-00161
• Device Sequence Number: 1807865
• Product Code: FWM
• UDI-Device Identifier: 10851795006121
• UDI-Public: (01)10851795006121(241)63501(17)181113
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2020

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: 11/13/2018
• Device Model Number: 63501
• Device Catalogue Number: 635
• Device Lot Number: 61399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 02/23/2020
• 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