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DISTRACTION, INTERNAL 51-360-30-09Recalls & reported problems

KLS-Martin L.P. · DIST, LEFORT 1, ZURICH TELE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118080509), received between Feb 7, 2017 and Aug 22, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Break1

Patient problems

  • Failure of Implant1
  • Impaired Healing1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO FREE TISSUE FROM THE DEVICE.

    Patient problems: Impaired Healing

    MAUDE report 8920802 ↗
  • InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED SOFT TISSUE WAS GETTING CAUGHT IN THE DISTRACTOR.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7732806 ↗
  • InjuryFeb 7, 2017Break

    DOCTOR SHAPED THE DISTRACTOR FOOT PLATES CUSTOM FOR THE PATIENT WHEN IT WAS POSITIONED IN THE CORRECT POSITION. AFTER USING 13 SCREWS ON EACH SIDE HE TURNED BOTH THE RIGHT AND LEFT SIDE DISTRACTORS 15-17MM AND THE LEFT SIDE DISTRACTOR BROKE AT THE WELD. DISTRACTOR WAS IMMEDIATELY REMOVED AND REPLACED WITH A BACKUP.

    Patient problems: Failure of Implant

    MAUDE report 6306989 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.