DISTRACTION, INTERNAL 51-424-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V · Class 2 · Implant
All models of DISTRACTION, INTERNAL (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118081285), received between Mar 2, 2018 and Nov 29, 2019 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break6
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Impaired Healing6
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2019Break; Break
IT WAS REPORTED THE DISTRACTOR WAS FOUND BROKEN UPON SCHEDULED REMOVAL.
Patient problems: Impaired Healing
MAUDE report 9391979 ↗InjuryApr 9, 2019Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8496398 ↗InjuryMar 26, 2019Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8451903 ↗InjuryFeb 15, 2019Break; Break
IT WAS REPORT THAT A DISTRACTOR BROKE. EXPECTED TO BE REMOVED ON AN UNDETERMINED DATE.
Patient problems: Impaired Healing
MAUDE report 8344771 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THE DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8298201 ↗InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DISTRACTOR WAS REMOVED AND REPLACED DUE TO THE PATIENT POOR BONE QUALITY.
Patient problems: Impaired Healing
MAUDE report 7764752 ↗MalfunctionMar 2, 2018Break; Break
IT WAS REPORTED THAT THE FOOTPLATE OF THE DISTRACTOR BROKE OFF. TREATMENT WAS COMPLETED, AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7309537 ↗
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
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-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 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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