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DISTRACTION, INTERNAL 51-508-15-09Recalls & reported problems

KLS-Martin L.P. · DIST, SYMPHYSIS, ZURICH 1, BOLOGNA, 2.0-2.3 MM SCREW, TI-6AL-4V · Class 2 · Implant

All models of DISTRACTION, INTERNAL (67)

Data updated Oct 16, 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 00888118099747), received between Apr 4, 2022 and May 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

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.

  • InjuryMay 25, 2022Break; Break

    IT WAS REPORTED THAT THE DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.

    Patient problems: Impaired Healing

    MAUDE report 14497979 ↗
  • InjuryApr 4, 2022Break; Break

    IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.

    Patient problems: Impaired Healing

    MAUDE report 14000653 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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