DISTRACTION, INTERNAL 50-347-07-09Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888118075604), received between May 11, 2018 and Jun 19, 2020 — classified as 6 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (4 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
- Osseointegration Problem4
- Migration or Expulsion of Device2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Impaired Healing3
- Inadequate Osseointegration2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10174533 ↗InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SCREWS PULLED OUT DURING ACTIVATION OF THE DISTRACTOR POSSIBLE DUE TO EARLY HEALING OF THE OSTEOTOMY. THE SCREWS WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9726392 ↗InjuryJan 2, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE SCREWS PULLED OUT OF THE BONE. SCREWS WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 9537644 ↗InjuryFeb 15, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND WILL REMAIN IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8344779 ↗InjuryMay 11, 2018Migration or Expulsion of Device; Osseointegration Problem; Migration or Expulsion of Device; Osseointegration Problem
IT WAS REPORTED THAT SCREWS WERE FOUND NO LONGER FIXATED IN MANDIBULAR BONE DURING THE CONSOLIDATION PERIOD OF A DISTRACTION CASE. THE PRODUCT WAS REMOVED. DOCTOR FELT ADEQUATE CONSOLIDATION HAD OCCURRED POST-DISTRACTION AND NO ADDITIONAL FIXATION METHODS WERE USED.
Patient problems: Inadequate Osseointegration
MAUDE report 7506059 ↗InjuryMay 11, 2018Migration or Expulsion of Device; Osseointegration Problem; Migration or Expulsion of Device; Osseointegration Problem
IT WAS REPORTED THAT SCREWS WERE FOUND NO LONGER FIXATED IN MANDIBULAR BONE DURING THE CONSOLIDATION PERIOD OF A DISTRACTION CASE. THE PRODUCT WAS REMOVED. DOCTOR FELT ADEQUATE CONSOLIDATION HAD OCCURRED POST-DISTRACTION AND NO ADDITIONAL FIXATION METHODS WERE USED.
Patient problems: Inadequate Osseointegration
MAUDE report 7506057 ↗
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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