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DISTRACTION, INTERNAL 51-401-50-09Recalls & reported problems

KLS-Martin L.P. · ACT ARM, RIGID, CARDANIC, CLIPPABLE, 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
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 00888118080721), received between Jul 25, 2017 and Jul 25, 2017 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Impaired Healing1

Recent adverse event reports

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

  • InjuryJul 25, 2017Fracture; Fracture

    DISTRACTOR WAS IMPLANTED ON (B)(6) 2017. WHEN THE PATIENT WOKE UP THE NEXT DAY THE DISTRACTOR ARM WAS BROKEN. ON (B)(6) 2017 THE DOCTOR REMOVED AND REPLACED THE BROKEN DEVICE WITH A NEW ONE.

    Patient problems: Impaired Healing

    MAUDE report 6740312 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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