DISTRACTION, INTERNAL 51-361-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, LEFORT 1, ZURICH TELE, RIGHT, 1.5-1.8 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 00888118080516), received between Dec 20, 2016 and Jul 25, 2024 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (5 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.
Reports received per month
Most reported problems
Device problems
- Break5
- Adverse Event Without Identified Device or Use Problem3
- Mechanical Problem1
Patient problems
- Impaired Healing5
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR BROKE DUE TO UNKNOWN REASONS. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 19825763 ↗InjuryApr 14, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR BROKE DURING DISTRACTION. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16742112 ↗InjuryApr 13, 2021Break; Break
IT WAS REPORTED THAT THE DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11657229 ↗InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO FREE TISSUE FROM THE DEVICE.
Patient problems: Impaired Healing
MAUDE report 8920799 ↗InjuryFeb 1, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DISTRACTOR WAS STICKING. THE DISTRACTOR WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8298198 ↗MalfunctionAug 8, 2018Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. FULL DISTRACTION WAS SUCCESSFULLY COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7764731 ↗InjuryDec 20, 2016Break
DISTRACTOR WELD BROKE AT THE ACTIVATION ARM. THE BROKEN PIECES WERE REMOVED. THE FOOT PLATES WERE LEFT IN PATIENT BILATERALLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6191430 ↗
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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