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DISTRACTION, INTERNAL 99-060-78-02Recalls & reported problems

KLS-Martin L.P. · DIST, MANDIBLE, MICRO ZURICH 2, END DRV, OPP 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118095107), received between May 16, 2018 and May 16, 2018 — classified as 1 malfunction.

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

  • Entrapment of Device1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 16, 2018Entrapment of Device; Entrapment of Device

    IT WAS REPORTED THE DISTRACTOR WOULD NOT ADVANCE AFTER PLACEMENT. IT WAS REPLACED DURING THE SAME SURGERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7518484 ↗

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