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DISTRACTION, INTERNAL 51-402-16-09Recalls & reported problems

KLS-Martin L.P. · TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, TI-6AL-4V · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118080776), received between Jan 6, 2017 and Feb 16, 2017 — classified as 2 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Detachment Of Device Component1
  • Positioning Problem1
  • Unintended Movement1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Code Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 16, 2017Break

    ON (B)(6) 2017 PATIENT SNAPPED BUTTRESS TUBE WHILE YAWNING. THE DISTRACTOR WAS REMOVED AND REPLACED WITH PLATES. PATIENT WAS INVOLVED IN PREVIOUSLY REPORTED EVENT UNDER MDR 9610905-2016-00059.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6335669 ↗
  • MalfunctionFeb 1, 2017Detachment Of Device Component; Unintended Movement

    DISTRACTOR FOOT PLATE BECAME DETACHED FROM THE DISTRACTOR TUBE AFTER ADVANCEMENT WAS COMPLETED. THE FOOT PLATE REMAINED FIXATED TO THE PATIENT. DOCTOR DID NOT THINK IT WAS NECESSARY TO REMOVE THE DEVICE EARLIER THAN PLANNED. PATIENT HAD REPORTED THAT THEY YAWNED/SNEEZED AND FELT A SHIFT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6293004 ↗
  • InjuryJan 6, 2017Break; Positioning Problem

    ON (B)(6) 2016 THE PATIENT'S MOTHER HAD DIFFICULTY MAKING THE DISTRACTOR TURN ON THE RIGHT SIDE. THE PATIENT CAME INTO THE CLINIC ON (B)(6) 2016 WHERE DR. (B)(6) ALSO HAD DIFFICULTY TURNING THE DEVICE ON THE RIGHT SIDE. AS HE WAS ASSERTING FORCE TO THE ACTIVATION ARM VIA THE PATIENT WRENCH, HE HEARD A SNAP. CT CONCLUDED THAT THE BUTTRESS TUBE HAD SNAPPED SUPERIOR TO THE SCREW CONNECTION BETWEEN DISTRACTOR BODY AND BUTTRESS TUBE. PATIENT UNDERWENT SURGERY THE SAME DAY TO REPLACE THE DISTRACTOR BODY AND BROKEN BUTTRESS TUBE. DURING THE PROCEDURE THE DOCTOR RETRACTED THE DISTRACTOR ON THE RIGHT SIDE, AND AGAIN THE BUTTRESS TUBE BROKE IN THE SAME PLACE. BUTTRESS TUBE WAS SWAPPED OUT FOR ANOTHER. THE RESIDENT AND FELLOW THOUGHT THAT WHILE RETRACTING THE DISTRACTORS, THE SIDES BECAME IN EVEN, PUTTING TOO MUCH LOAD ON THE RIGHT SIDE MAKING IT SNAP.

    Patient problems: No Code Available

    MAUDE report 6230629 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.