DISTRACTION, INTERNAL 51-526-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, MANDIBLE, HYPERDRIVE, 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
- 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 00888118099617), received between Mar 16, 2017 and Jun 12, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Detachment of Device or Device Component2
- Detachment Of Device Component1
- Difficult or Delayed Activation1
- Entrapment of Device1
- Fracture1
Patient problems
- Impaired Healing5
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A DISTRACTOR BECAME FRACTURED FOLLOWING 15 DAYS OF IMPLANTATION. IT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193871 ↗InjuryFeb 21, 2024Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18748205 ↗InjuryDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE ATTACHMENT SOCKET BECAME SEPARATED FROM RATCHET HOUSING.
Patient problems: Insufficient Information
MAUDE report 12964308 ↗InjuryDec 1, 2021Break; Break
A PATIENT CONDITION POSSIBLY CONTRIBUTED TO A DISTRACTOR BREAKAGE, IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12908173 ↗InjuryNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE ATTACHMENT SOCKET BECAME SEPARATED FROM RATCHET HOUSING.
Patient problems: Insufficient Information
MAUDE report 12749003 ↗InjuryJul 19, 2021Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12192965 ↗InjuryMay 11, 2020Entrapment of Device; Difficult or Delayed Activation; Entrapment of Device; Difficult or Delayed Activation
IT WAS REPORTED THE DISTRACTOR WOULD NOT TURN. DOCTOR'S OPINION IS MAYBE TISSUE WAS STUCK IN THE TRACK. THE PRODUCT WAS REMOVED PRIOR TO COMPLETION OF DISTRACTION.
Patient problems: Impaired Healing
MAUDE report 10042901 ↗InjurySep 12, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9007983 ↗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 7812535 ↗InjuryMar 16, 2017Break; Detachment Of Device Component
IT WAS REPORTED THE DISTRACTOR WAS OPEN TO ABOUT 25MM AND WAS USED TO RETRACT THE PATIENTS SKULL. AFTER ABOUT A WEEK THE END RATCHET SNAPPED OFF AND THE DEVICE WAS NOT ABLE TO RETRACT ANY FURTHER. IT IS BELIEVED TISSUE AND OR BONE GOT CAUGHT IN THE TRACK, WHICH CAUSED THE DEVICE TO BREAK. DEVICE WAS REMOVED ON (B)(6) 2017. DISTRACTOR WAS USED AS A RETRACTOR. THE USE OF THE DEVICE IN THIS MANNER IS CONSIDERED OFF INDICATIONS FOR USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6411143 ↗
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
- 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
- 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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