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

Model Number	N/A
Health Effect - Clinical Codes	Swelling (2091); No Code Available (3191)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not returned, and implantech reviewed production/manufacturing records, including labeling review.Results: no problem with the device was identified.Conclusions: implantech has concluded the event is a known, inherent risk associated with implant procedures.No problem with the device has been identified.
Event or Problem Description
Complainant reported that patient experienced serous fluid accumulation on the right side after bilateral placement with gluteal implants.The physician made multiple attempts to drain the right side, however swelling and serous fluid accumulation persisted.Approximately 9 months post-operatively, the right side device was explanted and replaced.

• Brand Name: CONTOURFLEX(TM) GLUTEAL IMPLANT ROUND
• Common Device Name: CONTOURED CARVING BLOCK IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 8106766
• Report Number: 2028924-2018-00009
• Device Sequence Number: 2069640
• Product Code: MIB
• UDI-Device Identifier: M724CCB521
• UDI-Public: M724CCB521
• Combination Product (Y/N): N
• PMA/510(K) Number: K052504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: CCB5-2
• Device Lot Number: 874027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/27/2018
• 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: 49 YR