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Forearm Plating System FreeFix Midshaft Ulna Plate, 157mmRecalls & reported problems

Skeletal Dynamics L.L.C. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841506115399), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Failure of Implant1
  • Implant Pain1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

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

  • MalfunctionJul 25, 2023Fracture; Fracture

    AN IMPLANTED MIDSHAFT ULNA PLATE BROKE 18 MONTHS AFTER SURGERY.

    Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

    MAUDE report 17390072 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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