Powerflex™ Pectoral Implant, Novack Style 2, SDM Size: 1, Left SideRecalls & reported problems
Implantech Associates, Inc. · Pectoral Implant · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724BNPI2T1L1), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Malposition of Device1
- Nonstandard Device1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2020Nonstandard Device; Malposition of Device; Appropriate Device Problem Term/Code Not Available
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.
Patient problems: No Information
MAUDE report 9700544 ↗
Other Implant, Muscle, Pectoralis devices
- Powerflex™ Pectoral Implant Size 4, RightImplantech Associates, Inc. · Implant, Muscle, Pectoralis2 reports
- AART Pectoralis Implant BAart · Implant, muscle, pectoralis1 report
- Pectoralis Implant ACP 2-2Hanson Medical, Inc. · Implant, Muscle, Pectoralis1 report
- Powerflex™ Pectoral Implant, Novack Style 2, SDM Size: 1, Right SideImplantech Associates, Inc. · Implant, Muscle, Pectoralis1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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