Powerflex™ Pectoral Implant, Novack Style 2, SDM Size: 1, Right SideRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724BNPI2T1R1), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2019Device Markings/Labelling Problem

  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".).

  Patient problems: No Code Available

  MAUDE report 8493235 ↗