MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. POWERFLEX (TM) PECTORAL IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed manufacturing records, sterilization records and product labeling.Results: no failure was detected.Conclusion: the possibility of serous fluid accumulation (seromas) is a known, inherent risk associated with implant surgery.
Event or Problem Description
Complainant reported that patient who had a previous set of pectoral implants, had them replaced with implantech pectoral implants.The patient subsequently developed recurring seromas on the right side only which were initially reported by the patient approximately 14 weeks post-operatively.The patient subsequently elected to have only the right side implant explanted and immediately replaced approximately 24 weeks post-operatively.Implantech followed up to check the status of the patient 3 weeks after replacement surgery, and the complainant reported that the patient was still have problems with seromas on the right side.The patient currently plans to have implants on both sides removed without immediate replacement.(implantech has initiated a new complaint file to investigate the new event.).

• Brand Name: POWERFLEX (TM) PECTORAL IMPLANT
• Common Device Name: PECTORAL IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 6311605
• Report Number: 2028924-2017-00001
• Device Sequence Number: 540046
• Product Code: MIC
• UDI-Device Identifier: M724ACPI4R1
• UDI-Public: M724ACPI4R1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: Physician
• Device Expiration Date: 07/01/2021
• Device Model Number: N/A
• Device Catalogue Number: ACPI-4R
• Device Lot Number: 866897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2005
• Initial Report FDA Received Date: 02/08/2017
• 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: 62 YR