DISTRACTION, INTERNAL 51-563-30-09Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, ZURICH 2, 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
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888118082145), received between Jan 5, 2017 and Oct 24, 2025 — classified as 13 injuries.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Activation Problem2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Human Factors Issue1
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Impaired Healing8
- Abrasion1
- Failure of Implant1
- Fall1
- Inadequate Osseointegration1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Activation Problem; Activation Problem
IT WAS REPORTED THE ACTIVATION ARM BECAME DETACHED FROM THE DISTRACTOR. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 23380120 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR WOULD NOT ADVANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 14552420 ↗InjuryJun 16, 2021Activation Problem; Activation Problem
IT WAS REPORTED A DISTRACTOR WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12008523 ↗InjurySep 18, 2020Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED WITH A NEW DEVICE.
Patient problems: Impaired Healing
MAUDE report 10553804 ↗InjuryDec 19, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9498307 ↗InjuryDec 16, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9476807 ↗InjuryMar 26, 2019Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE AND WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 8451884 ↗InjuryMar 19, 2019Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8433043 ↗InjurySep 28, 2018Break; Break
IT WAS REPORTED THAT DUE TO PATIENT BEING NON-COMPLIANT A DISTRACTOR BROKE. EXPECTED REMOVAL ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 7919300 ↗InjuryJul 12, 2017Fracture; Fracture
PATIENT HAD A CRANIAL DISTRACTOR IMPLANTED ON (B)(6) 2017. THE DISTRACTOR BROKE SOMETIME THEREAFTER. A SECOND SURGERY WAS COMPLETED TO REPLACE THE BROKEN DEVICE ON (B)(6) 2017. PATIENT'S MOTHER REPORTED THAT THE PATIENT PLAYED WITH THE DEVICE FREQUENTLY.
Patient problems: Inadequate Osseointegration
MAUDE report 6705195 ↗InjuryMar 7, 2017Break; Improper or Incorrect Procedure or Method
PATIENT CAME TO THE CLINIC WITH DEVICE BROKEN ALONG THE DRIVE SHAFT. THIS IS THE SECOND DEVICE THAT HAS BROKEN IN THE PATIENT. PREVIOUS EVENT WAS REPORTED ON MDR 9610905-2016-00058. DOCTOR BELIEVES THE PATIENT BROKE THIS AND PREVIOUS DEVICE DUE TO ABRASION/PUNCTURES OBSERVED ON ARM AND HAND FROM HITTING THE DEVICE. THIRD SURGERY IS PLANNED FOR (B)(6) 2017 TO REMOVE THE DISTRACTION.
Patient problems: Abrasion
MAUDE report 6384605 ↗InjuryJan 27, 2017Break; Use of Device Problem; Human Factors Issue
PATIENT FELL ONTO A TILE FLOOR AND THE IMPACT BROKE THE MOST DISTAL CRANIAL VAULT DISTRACTOR WHERE THE BODY WELDS TO THE FOOTPLATE. PATIENT WASN'T INJURED BUT DUE TO THE DEVICE BREAKING THE FAMILY TRAVELED BACK TO THE HOSPITAL TO HAVE IT LOOKED AT. THE CLINICAL DECISION WAS TO HAVE THE DISTRACTOR REMOVED AND REPLACED. THE SAME STOCK NUMBER WAS USED TO REPLACE THE DISTRACTOR.
Patient problems: Failure of Implant; Fall
MAUDE report 6282364 ↗InjuryJan 5, 2017Break
DURING FOLLOW UP APPOINTMENT PATIENT'S FAMILY SAID THEY HAD DIFFICULTY TURNING AFFECTED SIDE. DOCTOR WAS ABLE TO TURN THE DEVICE HOWEVER WAS UNABLE TO FEEL/HEAR ANY FEEDBACK THAT THE DEVICE WAS ADVANCING. DOCTOR UPPED TO 1 1/2 TURNS. ON (B)(6) 2016 THE PATIENT SHOWED UP TO FOLLOW UP APPOINTMENT AND THE DISTRACTOR WAS BROKEN. SECONDARY SURGERY WAS PERFORMED TO REMOVE AND REPLACE BROKEN DEVICE.
Patient problems: No Code Available
MAUDE report 6227080 ↗
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
- 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
- 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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