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DISTRACTION, INTERNAL 51-424-21-09Recalls & 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

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118081254), received between May 2, 2018 and Mar 19, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

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

  • Break3

Patient problems

  • Impaired Healing3

Recent adverse event reports

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

  • InjuryMar 19, 2019Break; Break

    IT WAS A REPORTED THAT A DISTRACTOR BROKE. THE DEVICE WILL BE REMOVED ON AN UNKNOWN DATE.

    Patient problems: Impaired Healing

    MAUDE report 8433046 ↗
  • InjuryOct 5, 2018Break; Break

    IT WAS REPORTED THAT THE DISTRACTORS BROKE. THE DISTRACTORS WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 7939733 ↗
  • MalfunctionMay 2, 2018Break; Break

    IT WAS REPORTED THE DISTRACTOR BROKE DURING THE DISTRACTION PERIOD. THE PATIENT ACHIEVED ENOUGH DISTRACTION AND DID NOT NEED ANOTHER.

    Patient problems: Impaired Healing

    MAUDE report 7480728 ↗

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.