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LEVEL ONE CMF 25-883-13-91Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118048097), received between Aug 11, 2020 and Sep 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 Problem2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Impaired Healing2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 9, 2021Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED SCREWS PULLED LOOSE DUE TO PATIENT NON-COMPLIANCE AND NECESSITATED REMOVAL OF THE SCREWS.

    Patient problems: Impaired Healing

    MAUDE report 12446982 ↗
  • InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

    IT WAS REPORTED THAT SCREWS BECAME LOOSE DUE TO BONE QUALITY AND WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 10393649 ↗

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.