MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVACK STYLE 2); CONTOURED CARVING BLOCK IMPLANT

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation involved physical evaluation of the device associated with report.Evaluation confirms that device labeled as left side was actually a right side device.Though a review of the device history record for the reported device found no errors or omissions that might account for the reported event, implantech has determined that this event is linked to a prior complaint investigation (refer to report # 2028924-2019-00004) in which a right side or bnpi2-t-1r was reported to actually be the left side or bnpi2-t-1l device.The complainant in the current report was contacted as part of prior complaint investigation and reported that device had already been implanted, and the doctor had no issues or comments associated with the device.At the time, the scope of event was limited to the 1 device.Based on the evidence from both complaint investigations, the probable cause of the reported event is a product mix-up (1:1 switch) between two product lots.The scope of this issue is now limited to the two devices associated with report 2028924-2019-00004 and this report 2028924-2020-00001 respectively.The outcome was incorrect labeling as evidence suggests a left side device was labeled as a right side device.Implantech attributes cause to a manufacturing error (i.E product mix-up), with a deficiency in quality control processes as a secondary cause.No further actions are required.
Event or Problem Description
The complainant reported that patient received pectoral implants bilaterally, and subsequently complained of dissatisfaction with result on the left side approximately 7 months post-operatively.Approximately 10 months post-operatively, the patient had left side device explanted and replaced due to displacement/patient dissatisfaction.Upon explant, the complainant reported that the device removed from the left side was actually a right side device.Both sides were found to be right sides.

• Brand Name: POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVACK STYLE 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: 9700544
• Report Number: 2028924-2020-00001
• Device Sequence Number: 11474147
• Product Code: MIC
• UDI-Device Identifier: M724BNPI2T1L1
• UDI-Public: M724BNPI2T1L1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K944163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: N/A
• Device Catalogue Number: BNPI2-T-1L
• Device Lot Number: 877112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/12/2020
• 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: 51 YR