DISTRACTION, INTERNAL, STERILE 51-405-42-71Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V · Class 2 · Implant
All models of DISTRACTION, INTERNAL, STERILE (22)
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 00888118114310), received between Nov 5, 2019 and Nov 12, 2020 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Impaired Healing5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2020Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10829433 ↗InjuryNov 12, 2020Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10829430 ↗InjurySep 11, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR BROKE AS A RESULT OF A FALL AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10521729 ↗InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DID NOT REACH FULL DISTRACTION. THE DISTRACTOR WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9682992 ↗InjuryFeb 7, 2020Break; Break
IT WAS REPORTED THE DISTRACTOR BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9682985 ↗InjuryNov 5, 2019Break; Break
IT WAS REPORTED THAT DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9280133 ↗
Other Cranial Distraction System devices
- DISTRACTION, INTERNAL, STERILE 51-563-30-71KLS-Martin L.P. · Cranial Distraction System7 reports
- DISTRACTION, INTERNAL, STERILE 25-025-12-71KLS-Martin L.P. · Cranial Distraction System1 report
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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