DISTRACTION, INTERNAL 51-564-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, ZURICH 2, END DRV, OPP 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
- 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 00888118082183), received between May 18, 2016 and Sep 23, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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 Problem2
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- Impaired Healing2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DISTRACTORS WOULD NOT ADVANCE, LIKELY DUE TO CONVERGENT VECTORS. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15473096 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DISTRACTORS STOPPED ADVANCING LIKELY DUE TO CONVERGENT VECTORS. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15352718 ↗InjuryMay 18, 2016Break; Improper or Incorrect Procedure or Method
A CRANIAL DISTRACTOR WAS IMPLANTED INTO A PEDIATRIC PATIENT. THE PATIENT'S PARENT ATTEMPTED TO REMOVE THE ACTIVATION ARM AND BROKE THE DISTRACTOR. THE SURGEON INSTRUCTED THEM NOT TO ATTEMPT TO REMOVE THE ACTIVATION ARM OR CARDANIC EXTENSION AGAIN TO AVOID ANOTHER BREAKAGE OF DEVICE. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REPLACE THE BROKEN DEVICE.
Patient problems: No Code Available
MAUDE report 5662622 ↗
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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