DISTRACTION, INTERNAL 50-348-05-09Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, 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
- 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 00888118075635), received between May 29, 2018 and Jul 11, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration2
- Impaired Healing1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A DURAL TEAR AND A CSF LEAK. THE SCREWS WERE REMOVED AFTER ACHIEVING THE DESIRED DISTRACTION DISTANCE.
Patient problems: Impaired Healing
MAUDE report 7678530 ↗InjuryMay 30, 2018Migration or Expulsion of Device; Osseointegration Problem; Migration or Expulsion of Device; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE SCREWS WERE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 7552578 ↗InjuryMay 29, 2018Migration or Expulsion of Device; Osseointegration Problem; Migration or Expulsion of Device; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE SCREWS WERE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 7550455 ↗
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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