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DISTRACTION, INTERNAL 51-423-25-09Recalls & reported problems

KLS-Martin L.P. · DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, RTCH, 1.0-1.2 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
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 00888118081209), received between Oct 4, 2016 and Oct 4, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryOct 4, 2016Loose or Intermittent Connection

    AFTER THE COMPLETION OF THE DISTRACTION PHASE THE SURGEON ATTEMPTED TO REMOVE THE ACTIVATION ARM. DURING THE ATTEMPTED REMOVAL, THE POSTERIOR LEFT FOOT PLATE BECAME LOOSE FORM THE DISTRACTION BODY. THE LEFT DISTRACTOR WAS REMOVED ON (B)(6) 2016.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5997698 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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