Skip to content

LEVEL ONE CMF 25-383-09-09Recalls & reported problems

KLS-Martin L.P. · PLATE, MINI, TLTS, SUBCONDYLAR, K SHP, W/TAB, LEFT, 2.0-2.5 MM SCREW, CP TITANIUM · 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 00888118039446), received between Mar 17, 2020 and Mar 17, 2020 — 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

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 17, 2020Break; Break

    IT WAS REPORTED A PLATE BROKE. THE PLATE WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 9841342 ↗

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.