DISTRACTION, INTERNAL 51-424-20-09Recalls & 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 (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118081247), received between Jun 8, 2018 and Dec 21, 2023 — classified as 4 injuries, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
- Installation-Related Problem1
Patient problems
- Impaired Healing4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2023Improper or Incorrect Procedure or Method; Installation-Related Problem; Improper or Incorrect Procedure or Method; Installation-Related Problem
A DISTRACTOR SEPARATED DUE TO IMPROPER BENDING AND CUTTING OF THE DEVICE CONTRARY TO THE DEVICE'S INSTRUCTIONS FOR USE.
Patient problems: Insufficient Information
MAUDE report 18371233 ↗InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HIT THEIR HEAD AND THE DISTRACTOR BROKE AS A RESULT OF THE IMPACT. IT NECESSITATED THE REMOVAL OF A PORTION OF THE DEVICE.
Patient problems: Impaired Healing
MAUDE report 15852880 ↗MalfunctionJan 22, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. EXPECTED REMOVAL DATE IN (B)(6) 2019.
Patient problems: Impaired Healing
MAUDE report 8266615 ↗InjurySep 24, 2018Break; Break
IT WAS REPORTED THAT THE DISTRACTOR BROKE. THE DISTRACTOR WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7901649 ↗InjuryJun 8, 2018Break; Break
IT WAS REPORTED THAT THE DISTRACTOR BROKE AND WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 7584155 ↗
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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