LEVEL ONE CMF 25-878-05-91Recalls & 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
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888118047694), received between Dec 15, 2016 and Aug 27, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Osseointegration Problem4
- Adverse Event Without Identified Device or Use Problem3
- Component Falling1
- Failure to Osseointegrate1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of Osseointegration1
Patient problems
- Impaired Healing6
- Device Embedded In Tissue or Plaque3
- Inadequate Osseointegration3
- Foreign Body In Patient2
- Failure of Implant1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
17 DAYS AFTER IMPLANT AND DURING DISTRACTION PHASE, DISTRACTOR SCREWS BECAME LOOSENED FROM 8-MONTH-OLD PATIENT'S BONE. SCREWS WERE UNDAMAGED AND INTACT WITH DISTRACTOR CONSTRUCT ON EXPLANT. THEY WERE REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 22902745 ↗InjuryMay 23, 2025Osseointegration Problem; Osseointegration Problem
IMAGING REVEALED PATIENT BONE RESORPTION AT MARGINS OF DEVICE TWELVE MONTHS AFTER IMPLANTATION AND CONSEQUENT LOOSENED FIXATION SCREWS. THIS WAS CONFIRMED AT EXPLANT. SCREWS WERE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 22078358 ↗InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE DUE TO PATIENT GRINDING THEIR TEETH. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 14498335 ↗InjuryMar 30, 2021Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE SCREWS BECAME LOOSE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 11591066 ↗InjuryJun 19, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10174531 ↗InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED SCREWS SECURING A PLATE WERE REMOVED DUE TO THE PATIENT HAVING TROUBLE WITH EYE MOBILITY UNRELATED TO THE IMPLANTS.
Patient problems: Impaired Healing
MAUDE report 9477035 ↗InjuryFeb 5, 2019Break; Break
IT WAS REPORTED THAT THE SCREWS BROKE, AND A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8306705 ↗InjuryNov 5, 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 8038588 ↗InjuryAug 24, 2018Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE LOOSE SCREWS WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7812527 ↗InjuryMay 16, 2018Break; Break
IT WAS REPORTED A SCREW HEAD BROKE OFF. THE THREADS OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7518481 ↗InjuryMar 6, 2018Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THE PLATES AND SCREWS WERE REMOVED DUE TO LOOSE SCREWS.
Patient problems: Impaired Healing; Inadequate Osseointegration
MAUDE report 7317587 ↗InjuryFeb 16, 2017Break
CHEIF ORAL SURGEON'S RESIDENT BROKE THE HEAD OF THE DRILL FREE SCREW WHILE IMPLANTING IN THE MIDFACE REGION. THERE WERE NO CONSEQUENCES TO THE PATIENT REPORTED.
Patient problems: Failure of Implant
MAUDE report 6335643 ↗InjuryJan 31, 2017Break; Component Falling
THE DOCTOR WAS REPAIRING AN INFRAORBITAL RIM FRACTURE IN THE PATIENT. AFTER DRILLING A PILOT HOLE, SHE THEN PROCEEDED TO PLACE THE SCREW INTO THE PREDRILLED HOLE. THE SCREW SNAPPED OFF SLIGHTLY BEFORE THE SCREW HEAD REACHED THE PLATE. THE BODY OF THE SCREW REMAINS IN THE PATIENT. NO REPORTED INJURIES OCCURRED.
Patient problems: Foreign Body In Patient
MAUDE report 6291327 ↗InjuryDec 15, 2016Break
THE SCREW BROKE OFF INTO THE PATIENTS BONE. A PORTION OF THE SCREW WAS LEFT IN THE BONE DUE TO BEING UNABLE TO REMOVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 6177586 ↗
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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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