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

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: an analysis of production records was performed, as device was not returned.Results: no problem with the device has been found.Conclusion: the event is a known inherent risk of the device, and is an adverse event associated with the procedure.No problem with the device has been detected.
Event or Problem Description
Complainant reported that patient complained of major pain, possibly due to shifting of the implants.Devices were explanted and replaced bilaterally approximately 8 months post-operatively.(this report is for the right side device.Refer to 2028924-2018-00011 for report on the left side device involving the same patient and same event.).

• Brand Name: CONTOURFLEX(TM) GLUTEAL IMPLANT ROUND (NATURAL CONTOUR)
• Common Device Name: CONTOURED CARVING BLOCK IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 8206645
• Report Number: 2028924-2018-00010
• Device Sequence Number: 13970563
• Product Code: MIB
• UDI-Device Identifier: M724CCB5NC31
• UDI-Public: M724CCB5NC31
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 12/31/2018

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: 09/13/2022
• Device Model Number: N/A
• Device Catalogue Number: CCB5-NC-3
• Device Lot Number: 873292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/31/2018
• 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: 24 YR