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DISTRACTION, INTERNAL 99-461-66-01Recalls & reported problems

KLS-Martin L.P. · DIST, ZURICH 2, MODULAR, END DRV, BODY ONLY, RTCH, 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 00888118113740), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Detachment of Device or Device Component1

Patient problems

  • Impaired Healing1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 30, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A DISTRACTOR FASTENING SCREW CAME LOOSE. ADDITIONAL SURGERY WAS NEEDED TO TIGHTEN THE SCREW.

    Patient problems: Impaired Healing

    MAUDE report 11591063 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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