MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. CONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2; CONTOURED CARVING BLOCK IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report addresses the right side device.This is the same event, same patient that is being reported in report # 2028924-2019-00002 which addresses the left side device.
Event or Problem Description
Complainant reported that patient with gluteal implants had devices explanted bilaterally approximately 7 years and 8 months post-operatively due to pain and migration.Upon explant, the devices were found in several pieces.Complainant confirms devices were carved at the time of implantation.Note: this report addresses the right side device.This is the same event, same patient that is being reported in report # 2028924-2019-00002 which addresses the left side device.

• Brand Name: CONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2
• Common Device Name: CONTOURED CARVING BLOCK IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 8294315
• Report Number: 2028924-2019-00003
• Device Sequence Number: 19337341
• Product Code: MIB
• UDI-Device Identifier: M724CCB621
• UDI-Public: M724CCB621
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 03/01/2016
• Device Model Number: N/A
• Device Catalogue Number: CCB6-2
• Device Lot Number: 839108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• 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