DISTRACTION, INTERNAL, STERILE 51-556-20-71Recalls & reported problems
KLS-Martin L.P. · DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V · Class 2 · Implant
All models of DISTRACTION, INTERNAL, STERILE (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118105356), received between Oct 1, 2020 and Apr 27, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Installation-Related 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Installation-Related Problem1
- Material Deformation1
- Use of Device Problem1
Patient problems
- Impaired Healing4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2023Installation-Related Problem; Installation-Related Problem
UPON ACTIVATION, DISTRACTOR FOOTPLATE WAS OBSERVED TO BE BENDING ON CT SCAN DUE TO INCOMPLETE INSTALLATION PROCEDURE. IT WAS REMOVED AND REPLACED AND NEW DISTRACTOR PERFORMED AS EXPECTED.
Patient problems: Impaired Healing
MAUDE report 16824391 ↗InjurySep 23, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED PATIENT'S JAW WOULD NOT CLOSE, LIKELY DUE TO CONVERGENT VECTORS. THEY WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 15473739 ↗InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DISTRACTOR WAS NOT TURNING. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13793281 ↗InjuryOct 1, 2020Material Deformation; Material Deformation
IT WAS REPORTED A DISTRACTOR BENT DUE TO THE PATIENT'S ANATOMY AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10617094 ↗
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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