DISTRACTION, INTERNAL 51-426-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, MANDIBLE, ZURICH 2, WILLIAMS, END DRV, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118081360), received between May 26, 2017 and Jun 22, 2018 — classified as 2 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
- Break1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2018Break; Break
IT WAS REPORTED THE DISTRACTOR BROKE DURING CONSOLIDATION, IT WAS NOTICED BROKEN DURING REMOVAL OF THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7630317 ↗InjuryMay 26, 2017Fracture; Fracture
PATIENT UNDERWENT A MANDIBULAR DISTRACTION. TWO OF THE DISTRACTORS BROKE AT THE PROXIMAL PLATE ON BOTH SIDES OF THE ROD. RIGHT SIDE MAINTAINED DISTRACTION LENGTH, BUT THE LEFT SIDE DID NOT. THE BREAK IS BELIEVED TO HAVE OCCURRED DURING THE CONSOLIDATION PHASE. A SCAN WAS TAKEN IN FEBRUARY AND EVERYTHING WAS OK. WHEN PATIENT UNDERWENT ANOTHER SCAN ON (B)(6) 2017 IT APPEARED THE DISTRACTORS BROKE OFF. PATIENT WENT BACK TO THE OPERATING ROOM (OR) ON (B)(6) 2017 AND BOTH DISTRACTORS WERE REMOVED. THE PATIENT HAD FINISHED THE CONSOLIDATION PHASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6593890 ↗
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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