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AcuTie STW1101Recalls & reported problems

Acute Innovations LLC · AcuTie Sternum Plate · Class 2

Data updated Oct 16, 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 10814493010753), received between Dec 13, 2016 and Dec 13, 2016 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Discomfort1
  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • InjuryDec 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PLATE WAS REMOVED FROM PATIENT BECAUSE THE SURGEON APPARENTLY DID NOT CUT THE WIRE SHORT ENOUGH AND THE PATIENT WAS HAVING SOME DISCOMFORT. SAID THEY ALWAYS CUT THE WIRE AS SHORT AS THEY CAN BUT THIS PARTICULAR PATIENT WAS VERY THIN, SO THEY'RE THINKING THIS MAY HAVE PLAYED A PART.

    Patient problems: Discomfort; Patient Problem/Medical Problem

    MAUDE report 6170559 ↗

Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices

All Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices →

Sources and updates

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