LEVEL ONE CMF 25-882-13-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, TLTS, TI-6AL-4V · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888118047915), received between Sep 14, 2018 and May 20, 2021 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Device Embedded In Tissue or Plaque5
- Impaired Healing1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED SCREWS BROKE, POSSIBLY DUE TO THE PATIENT'S NONCOMPLIANCE, AND REQUIRED REMOVAL.
Patient problems: Impaired Healing
MAUDE report 11854616 ↗InjuryApr 9, 2019Break; Break
IT WAS REPORTED A SCREW HEAD BROKE OFF DURING IMPLANTATION. A PORTION REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8496400 ↗InjuryFeb 25, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND A PORTION REMAIN IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8367371 ↗InjuryFeb 5, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8306711 ↗InjurySep 14, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7877976 ↗MalfunctionSep 14, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7877969 ↗
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.