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LEVEL ONE CMF 25-772-11-91Recalls & reported problems

KLS-Martin L.P. · SCREW, CROSSDRIVE, TLTS, TI-6AL-4V · Class 2 · Implant

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 00888118045744), received between Mar 31, 2017 and Mar 31, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment Of Device Component1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryMar 31, 2017Break; Detachment Of Device Component

    THE LOCKING SCREW SHEARED OFF AS IT WAS BEING TORQUED IN. BROKE AT THE BONE LEVEL AND WAS LEFT IN THE PATIENT. NO OTHER ISSUES. THE REST OF THE PLATE WAS FIXATED WITHOUT COMPLICATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 6449192 ↗

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.