DISTRACTION, INTERNAL 51-509-15-09Recalls & reported problems
KLS-Martin L.P. · DIST, SYMPHYSIS, ZURICH 1, ROTTERDAM, 2.0-2.3 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
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118099761), received between Jan 12, 2018 and Dec 29, 2021 — 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
- Fracture2
- Device Abrasion From Instrument Or Another Object1
- Material Twisted/Bent1
Patient problems
- Impaired Healing5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2021Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE DUE TO PATIENT NON-COMPLIANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13109765 ↗InjuryNov 23, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DISTRACTOR FOOTPLATES DEFORMED DURING TREATMENT. THE DISTRACTOR WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10884242 ↗InjuryAug 11, 2020Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10393614 ↗InjuryJan 12, 2018Fracture; Device Abrasion From Instrument Or Another Object; Fracture; Device Abrasion From Instrument Or Another Object
IT WAS REPORTED THAT THE DISTRACTOR WAS NOT HOLDING DISTRACTION. LATER, A FRACTURE OF AND APPARENT INSTRUMENT DAMAGE TO THE PLATE WAS DISCOVERED AND THE DEVICE WAS REMOVED AND REPLACED WITH FIXED PLATES ON (B)(6) 2017.
Patient problems: Impaired Healing
MAUDE report 7187621 ↗InjuryJan 12, 2018Fracture; Fracture
IT WAS REPORTED THE DISTRACTOR WAS NOT HOLDING DISTRACTION. LATER, A FRACTURE IN THE PLATE WAS DISCOVERED AND THE DEVICE WAS REMOVED AND REPLACED WITH PLATES ON (B)(6) 2017.
Patient problems: Impaired Healing
MAUDE report 7187617 ↗
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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