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DISTRACTION, INTERNAL, STERILE 51-410-23-71Recalls & reported problems

KLS-Martin L.P. · ACT ARM, RIGID, REMOTE DETACH, CONCEALED TIP, TI-6AL-4V · Class 2 · Implant

All models of DISTRACTION, INTERNAL, STERILE (22)

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 00888118129420), received between Nov 11, 2022 and Nov 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Separation Failure” (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

  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryNov 11, 2022Separation Failure; Separation Failure

    IT WAS REPORTED THAT THE ACTIVATION ARM WOULD NOT RELEASE INITIALLY DUE TO BIOMATERIAL INTERFERENCE. IT WAS REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15784259 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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