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

Model Number	63501
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant analysis showed silicone debris in the posterior valve channel, inhibiting seal of the valve and causing a leak.
Event or Problem Description
Deflation resulting in explantation.
Additional Manufacturer Narrative
Explant analysis showed silicone debris in the posterior valve channel, inhibiting seal of the valve and causing a leak.
Event or Problem Description
Deflation resulting in explantation.

• Brand Name: IDEAL IMPLANT STRUCTURED IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT,
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED; 14481 quorum drive; suite 925; dallas, tx TX 75254
• MDR Report Key: 9582197
• Report Number: 3011491947-2020-00028
• Device Sequence Number: 3244115
• Product Code: FWM
• UDI-Device Identifier: 10851795006121
• UDI-Public: (01)10851795006121(241)63501(17)220211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 02/11/2022
• Device Model Number: 63501
• Device Catalogue Number: 635
• Device Lot Number: 664134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 01/13/2020
• 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: 45 YR