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LEVEL ONE CMF 25-774-11-91Recalls & 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 00888118046307), received between Jun 18, 2021 and Jun 18, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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

  • Osseointegration Problem1

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.

  • InjuryJun 18, 2021Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED SCREWS BECAME LOOSE AND WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 12028688 ↗

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.