DISTRACTION, INTERNAL, STERILE 51-424-25-71Recalls & 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, STERILE (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118104861), received between Jan 14, 2021 and Dec 8, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Activation Problem1
Patient problems
- Impaired Healing3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2021Activation Problem; Activation Problem
IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS DONE TO FLUSH OUT A BLOCKAGE THAT PREVENTED THE DEVICE FROM TURNING AS EXPECTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT. MDR 9610905-2021-00121.
Patient problems: Impaired Healing
MAUDE report 12964304 ↗InjuryFeb 17, 2021Break
IT WAS REPORTED A DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11340214 ↗InjuryJan 14, 2021Break; Break
THE DISTRACTOR BROKE DUE TO PATIENT MOVEMENT. IT IS EXPECTED TO BE REMOVED AND REPLACED (B)(6) 2021.
Patient problems: Impaired Healing
MAUDE report 11172792 ↗
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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