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

Model Number	N/A
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records, and product labeling.Results: no failure was detected.Conclusion: the possibility of serous fluid accumulations (seromas) is a know, inherent risk associated with implant surgery.
Event or Problem Description
Complainant reported that after explant and immediate replacement of prior right side pectoral implant (refer to mdr# 2028924-2017-00001), that the patient has had continuing problems with recurring seromas on the right side.Approximately 6 weeks after replacement device was implanted, the pectoral implants were explanted bilaterally due to the recurring seromas on the right side.Implantech has elected to report this event although the patient symptomology that led to the reportable intervention was present in the patient prior to the device being implanted.

• 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: 6431805
• Report Number: 2028924-2017-00003
• Device Sequence Number: 58584
• Product Code: MIC
• UDI-Device Identifier: M724ACPI4R1
• UDI-Public: M724ACPI4R1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: 11/28/2021
• Device Model Number: N/A
• Device Catalogue Number: ACPI-4R
• Device Lot Number: 869068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/24/2017
• 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