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DISTRACTION, INTERNAL 51-350-30-09Recalls & reported problems

KLS-Martin L.P. · DIST, MANDIBLE, ZURICH TELE, 1.5-1.8 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118080493), received between Nov 7, 2016 and Sep 29, 2017 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • Fall1
  • Impaired Healing1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2017Fracture; Fracture

    DISTRACTOR STOPPED TURNING AND A FOOT PLATE BROKE OFF THE DISTRACTOR BODY. DEVICE WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH A DIFFERENT DISTRACTOR.

    Patient problems: Impaired Healing

    MAUDE report 6905729 ↗
  • InjuryNov 7, 2016Break

    DISTRACTOR BROKE AT THE WELD BETWEEN THE DISTRACTION MECHANISM AND THE FOOT PLATE. PATIENT FELL OF THE SLIDE DURING THE CONSOLIDATION PERIOD. ITEM WAS REMOVED AND REPLACED BY THE SAME ITEM NUMBER.

    Patient problems: Fall

    MAUDE report 6082871 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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