DISTRACTION, INTERNAL 51-401-91-09Recalls & reported problems
KLS-Martin L.P. · EXTENSION, CARDANIC, FOR ACT ARM, 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
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888118080745), received between Jun 30, 2016 and Feb 27, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Detachment Of Device Component3
- Fracture1
- Loose or Intermittent Connection1
- Premature Separation1
Patient problems
- Impaired Healing4
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Fracture
IT WAS REPORTED AN ACTIVATION ARM BECAME FRACTURED FROM THE DISTRACTOR FOLLOWING APPROXIMATELY 6 WEEKS OF IMPLANTATION. THE ACTIVATION ARM WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 24469116 ↗InjurySep 30, 2022Premature Separation; Premature Separation
IT WAS REPORTED A CARDANIC EXTENSION SEPARATED FROM THE DISTRACTOR POSSIBLY DUE TO PATIENT NON-COMPLIANCE.
Patient problems: Impaired Healing
MAUDE report 15509585 ↗InjurySep 2, 2022Break; Break
IT WAS REPORTED THE CARDANIC EXTENSION BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15352723 ↗InjuryOct 15, 2020Break; Break
IT WAS REPORT THAT A CARDANIC JOINT BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10683425 ↗InjuryOct 15, 2018Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7966132 ↗InjuryAug 24, 2018Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE DURING IMPLANTATION. IT WAS REMOVED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7812536 ↗InjuryMay 26, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component
DISTRACTORS WERE PLACED ON THURSDAY (B)(6) 2017. WHEN THEY TRIED TO ACTIVATE THE NIGHT OF (B)(6) 2017 THE CARDANIC EXTENSION SNAPPED IN HALF. THE DISTRACTOR ACTIVATION IS ACCESSIBLE AND THE EXTENSION ARM IS GOING TO BE SWAPPED OUT IN CLINIC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6593902 ↗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 5997666 ↗InjuryJun 30, 2016Detachment Of Device Component
THE CARDANIC EXTENTION WAS FOUND DETACHED FROM THE DISTRACTOR WHILE PATIENT WAS ASLEEP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5762264 ↗InjuryJun 30, 2016Detachment Of Device Component
THE CARDANIC EXTENSION WAS FOUND DETACHED FROM THE DISTRACTOR WHILE THE PATIENT SLEEP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5762260 ↗
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
- LEVEL ONE CMF 50-795-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 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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