DISTRACTION, INTERNAL 51-410-33-09Recalls & reported problems
KLS-Martin L.P. · ACT ARM, RIGID, REMOTE DETACH, 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
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118080929), received between Oct 4, 2016 and Jan 28, 2022 — classified as 5 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
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
Patient problems
- Impaired Healing3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ACTIVATION ARM WOULD NOT RELEASE. IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 13388558 ↗InjuryNov 24, 2021Break; Break
IT WAS REPORTED THAT A DISTRACTOR ARM BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12871912 ↗InjuryApr 13, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE QUICK RELEASE ARM WOULD NOT DETACH AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11657225 ↗InjurySep 12, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9007974 ↗InjuryOct 4, 2016Loose or Intermittent Connection
AFTER THE COMPLETION OF THE DISTRACTION PHASE THE SURGEON ATTEMPTED TO REMOVE THE ACTIVATION ARM. DURING THE ATTEMPTED REMOVAL, THE POSTERIOR LEFT FOOT PLATE BECAME LOOSE FORM THE DISTRACTION BODY. THE LEFT DISTRACTOR WAS REMOVED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5997645 ↗
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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