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DISTRACTION, INTERNAL 51-400-30-09Recalls & reported problems

KLS-Martin L.P. · ACT ARM, FLEXIBLE, CARDANIC, TI-6AL-4V · Class 2 · Implant

All models of DISTRACTION, INTERNAL (67)

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 00888118080592), received between Mar 2, 2018 and Mar 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 2, 2018Detachment Of Device Component; Detachment Of Device Component

    IT WAS REPORTED THAT THE DISTRACTOR'S FLEXIBLE ARM EXTENSION DISENGAGED. NO INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7309542 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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