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DISTRACTION, INTERNAL 51-565-09-09Recalls & reported problems

KLS-Martin L.P. · DIST, RAPID PALATAL EXPANDER, 2.0-2.3 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 00888118099631), received between Jan 31, 2017 and Jan 31, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Bent” (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

  • Bent1

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.

  • InjuryJan 31, 2017Bent

    RECEIVED (B)(4) STATING THAT AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT THE DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION. DEVICE DISTRACTED AS PLANNED. AT THIS TIME NO ADDITIONAL SURGERIES PLANNED OTHER THAN THE REMOVAL OF THE DEVICE. PATIENT IS DOING WELL AND NOT HAVING ANY ISSUES DISTRACTING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6291338 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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