DISTRACTION, INTERNAL 50-347-07-61Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118113405), received between Aug 23, 2023 and May 2, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. 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
- Loss of Osseointegration2
- Adverse Event Without Identified Device or Use Problem1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration3
- Neonatal Deformities1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED DISTRACTOR SCREWS BECAME LOOSE FROM COMPROMISED BONE DURING DISTRACTION. THEY WERE REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 21950210 ↗InjuryOct 31, 2024Loss of Osseointegration; Loss of Osseointegration
PHYSICIAN REPORTED A DISTRACTOR SCREW BECAME LOOSE FROM PATIENT'S BONE DUE TO POOR BONE QUALITY. PHYSICIAN SPECIFICALLY NOTED DEVICE DID NOT FAIL OR HAVE ANY ISSUES. DEVICE WAS REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 20577387 ↗InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SEVERED COMPROMISED BONE FRAGMENT INTO WHICH DISTRACTOR FOOTPLATE SCREWS WERE IMPLANTED DID NOT SUPPORT DISTRACTION.
Patient problems: Neonatal Deformities
MAUDE report 18584282 ↗InjuryAug 23, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT SCREWS SECURING A DISTRACTOR BECAME LOOSE FROM BONE. THE PHYSICIAN REMOVED THE SCREWS AND REPLACED THEM WITH THE SAME SIZE AND MODEL SCREWS WHILE LEAVING THE DISTRACTOR IN PLACE. THE SCREWS WERE NOTED TO BE INTACT AND UNDAMAGED UPON EXPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 17607193 ↗
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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