LEVEL ONE CMF 25-879-07-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE CMF (150)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888118047793), received between Dec 6, 2016 and May 20, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Osseointegration Problem9
- Adverse Event Without Identified Device or Use Problem3
- Break3
- Loss of Osseointegration2
- Fracture1
- Installation-Related Problem1
- Patient-Device Incompatibility1
Patient problems
- Impaired Healing11
- Inadequate Osseointegration2
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2025Installation-Related Problem; Installation-Related Problem
A CMF SCREW FIXATING A PLATE WAS FOUND TO HAVE BEEN INSTALLED ALONG EDGE OF BONE, DAMAGING CORTEX. IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 22054658 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CMF SCREWS IMPLANTED IN A RESCUE REVISION PROCEDURE ON PATIENT WITH KNOWN POOR BONE QUALITY BECAME LOOSE AFTER IMPLANT. EXPLANTED SCREWS WERE INTACT AND UNDAMAGED. PATIENT WAS RE-PLATED IN A SECOND REVISION PROCEDURE.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 20698675 ↗InjuryNov 17, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED A SCREW HAD BECOME LOOSE POSSIBLY DUE TO PATIENT NONCOMPLIANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18165254 ↗InjuryApr 5, 2023Osseointegration Problem; Osseointegration Problem
SCREWS USED TO SECURE A MANDIBULAR IMPLANT TO A PATIENT'S MANDIBLE WERE FOUND TO BE TOO SHORT TO SECURE THE IMPLANT TO THE BONE AND WERE REMOVED AND REPLACED WITH LONGER SCREWS.
Patient problems: Inadequate Osseointegration
MAUDE report 16686764 ↗InjuryOct 19, 2022Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A SINGLE SCREW WAS FOUND TO BE LOOSE. ALL OTHER SCREWS AND FIXATION PLATE REMAINED SECURE. DOCTOR ELECTED TO RE-PLATE THE PATIENT.
Patient problems: Impaired Healing
MAUDE report 15636012 ↗InjurySep 30, 2022Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT DRILL FREE SCREWS PREVIOUSLY IMPLANTED INTO A PATIENT HAD BECOME LOOSE AND THE PHYSICIAN ELECTED TO REMOVE THEM.
Patient problems: Insufficient Information
MAUDE report 15509458 ↗InjuryDec 20, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT TWO SCREWS BECAME LOOSE DUE TO PATIENT'S ANATOMY. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13044594 ↗InjuryDec 2, 2021Osseointegration Problem; Osseointegration Problem
InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THE SCREWS PULLED FROM THE BONE DUE TO PATIENT NON-COMPLIANCE. PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10748555 ↗InjuryOct 15, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS BECAME LOOSE DUE TO PATIENT NONCOMPLIANCE. SCREWS WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10683436 ↗InjuryMar 26, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT WAS NOT COMPLIANT WITH PHYSICIAN'S INSTRUCTIONS.
Patient problems: Impaired Healing
MAUDE report 9885077 ↗InjuryFeb 19, 2020Osseointegration Problem; Osseointegration Problem
InjuryOct 14, 2019Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THE SCREWS CAME LOOSE. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9183699 ↗InjuryFeb 25, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS CAME LOOSE, AND THE PRODUCT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8367376 ↗InjuryOct 29, 2018Break; Break
IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8016679 ↗InjuryAug 17, 2018Break; Break
IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. THE SCREW WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7793988 ↗InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE SCREWS WERE REMOVED AND REPLACED DUE TO REPOSITIONING OF THE PLATE.
Patient problems: Impaired Healing
MAUDE report 7651586 ↗InjuryAug 16, 2017Fracture; Fracture
WHILE THE SCREW WAS BEING IMPLANTED INTO THE PLATE WITH A RIGHT ANGLE SCREWDRIVER, THE SCREW HEAD BROKE OFF. THE BODY OF THE SCREW WAS LEFT IN THE PATIENT'S MANDIBLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6796757 ↗InjuryDec 6, 2016Break
SURGEON WAS PLATING A LEFT ANGLE FRACTURE. THE SURGEON PRE-DRILLED A PILOT HOLE USING A RIGHT ANGLE DRILL, AND THEN PROCEEDED TO SCREW THE IMPLANT WITH THE DRILL FREE SCREW. THE SCREW HEAD BROKE OFF WHILE BEING IMPLANTED INTO THE PATIENTS MANDIBLE. NO CONSEQUENCES TO THE PATIENT DUE TO THE SCREW BREAKING OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6147420 ↗
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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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