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DISTRACTION, INTERNAL 51-556-20-09Recalls & reported problems

KLS-Martin L.P. · DIST, LEFORT 1, ZURICH 2, LEFT, 1.5-1.8 MM SCREW, 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118082060), received between Oct 21, 2019 and Oct 25, 2019 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • Impaired Healing2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE DISTRACTOR WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 9238648 ↗
  • InjuryOct 21, 2019Break; Break

    IT WAS REPORTED THAT THE DISTRACTOR BROKE AND WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 9214774 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page