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DISTRACTION, EXTERNAL 51-604-50-09Recalls & reported problems

KLS-Martin L.P. · DIST, CRANIO MANDIBLE FIXATOR, W/WEDGE, 18 MM STEP, 2.7 MM PIN, 2.0-2.3 MM SCREW, TI-6AL-4V · Class 2 · Implant

Data updated Oct 18, 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 00888118083258), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Use of Device Problem1

Patient problems

  • Impaired Healing1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 15, 2018Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THE DISTRACTOR WAS TURN THE INCORRECT WAY CAUSING PAIN AND THE PINS TO BECOME LOOSE. THE PINS WERE REMOVED, AND THE DISTRACTOR WILL BE REMOVED ON AN UNKNOWN DATE.

    Patient problems: Impaired Healing; Pain

    MAUDE report 7966121 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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