DISTRACTION, INTERNAL 50-347-09-09Recalls & 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
- 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 00888118075611), received between Jun 13, 2017 and Feb 15, 2019 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fracture1
- Osseointegration Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Impaired Healing1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS CAME LOOSE. THE SCREWS WERE TIGHTENED AND ADDITIONAL SCREWS ADDED.
Patient problems: Impaired Healing
MAUDE report 8344773 ↗InjuryMar 12, 2018Break; Break
IT WAS REPORTED THAT HEADS OF THREE SCREWS BROKE OFF DURING IMPLANTATION. THE THREADS OF THE SCREWS REMAIN IN THE PATIENT. IFU (B)(4) STATES "CARE IS TO BE USED WHEN SEATING MINI OR MICRO CRANIO-MAXILLO BONE SCREWS. INTRAOPERATIVE FRACTURE OF SCREWS CAN OCCUR IF EXCESSIVE FORCE (TORQUE) OR MECHANICAL OVERLOAD IS APPLIED WHILE SEATING BONE SCREWS INTO POSITION."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7330124 ↗InjuryJun 13, 2017Fracture; Fracture
DURING THE REMOVAL OF ZURICH DISTRACTORS TWO SCREW TIPS WERE BROKEN. THE BROKEN SCREWS WERE LEFT IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6636145 ↗
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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