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DISTRACTION, INTERNAL 51-540-25-09Recalls & reported problems

KLS-Martin L.P. · DIST, LEFORT 1, TSMD, ANTWERP TRANS SINUSOIDAL, RIGID ARM, 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
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 00888118081933), received between Oct 14, 2016 and Oct 14, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

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 14, 2016Device Dislodged or Dislocated

    DEVICE ACTIVATION ARM SNAPPED OFF DURING THE DISTRACTION PROCESS. REPLACED BOTTOM HALF OF THE DISTRACTOR WITH ACTIVATION ARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6031542 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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