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

Model Number	N/A
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Methods: included testing of actual/suspected device and review of production records.Results: incorrect labeling.Conclusion: cause traced to manufacturing and quality control deficiency.Summary: investigation involved physical evaluation of the device associated with report.Though device had been separated from original packaging, evidence indirectly supported that device labeled as right side implant had logo imprint and dimensions that correspond to the left side device.The only other product manufactured on the same lot was evaluated and conformed to logo imprint and dimensions of a right side device.Review of device history records and lot distribution records has not identified any evidence to support that there was a product mix-up which involved any other products.If valid, the scope of this issue is currently limited to the one device associated with this report.The results are recorded as incorrect labeling as evidence suggests a left side device was labeled as a right side device.Implantech attributes cause to a manufacturing error, with a deficiency in the quality control processes as a secondary cause.
Event or Problem Description
The patient was scheduled for bilateral placement of pectoral implant.The patient had already been placed under anesthesia, and pockets had been created for the implants.Complainant reported that device labeled as a bnpi2-t-1r was actually a bnpi2-t-1r, therefore they had 2 left side implant.The complainant attempted to use an available back-up device which was a different catalog item, however the difference in dimensions led complainant to decide back-up was not suitable.Complainant terminated the surgery without successful implantation of devices on either right or left side.Complainant reported that patient had successful bilateral implant surgery 12 days after initial surgery attempt.(note: implantech selected "other serious" rather than "required intervention." because implantation of these devices is elective so 2nd surgery to implant devices was not deemed to be required.Nevertheless, the patient having to undergo 2 surgeries to have devices implanted rather than one was deemed by implantech to be an important medical event that qualified as "other serious".).

• Brand Name: POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVAK 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: 8493235
• Report Number: 2028924-2019-00004
• Device Sequence Number: 1315260
• Product Code: MIC
• UDI-Device Identifier: M724BNPI2T1R1
• UDI-Public: M724BNPI2T1R1
• Combination Product (Y/N): N
• PMA/510(K) Number: K944163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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-1R
• Device Lot Number: 877113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/08/2019
• 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: Other
• Patient Age: 34 YR