DISTRACTION, INTERNAL 51-605-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, MICRO ZURICH 2, FORREST, END DRV, RTCH, 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118083319), received between Feb 1, 2017 and Nov 9, 2023 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment of Device or Device Component1
- Human Factors Issue1
Patient problems
- Impaired Healing2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN INFANT PATIENT ROLLED OVER A DISTRACTOR'S REMOTE DETACHABLE ACTIVATION ARM IN PATIENT'S CRIB BREAKING THE ACTIVATION ARM OFF OF THE DISTRACTOR.
Patient problems: Impaired Healing
MAUDE report 18104252 ↗InjuryOct 15, 2020Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. THE DEVICE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10683427 ↗MalfunctionMar 22, 2018Break; Human Factors Issue; Break; Human Factors Issue
IT WAS REPORTED THE PATIENT FELL WHILE WALKING AND THE LEFT CRANIAL DISTRACTOR BROKE. NO INJURY REPORTED. DEVICE WAS REMOVED ON THE PLANNED EXPLANT DATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7361531 ↗MalfunctionFeb 1, 2017Break
THE GUARDIAN OF THE PATIENT WAS MAKING THE FINAL DISTRACTION TURN WHEN THE DEVICE BROKE. DOCTOR STATED IT WAS NOT AN ISSUE AS THE DISTRACTION HAD ALREADY BEEN COMPLETED. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6293030 ↗
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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