LEVEL ONE CMF 25-878-07-91Recalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888118047731), received between Apr 4, 2016 and Dec 19, 2025 — classified as 9 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of Osseointegration1
- Material Integrity Problem1
- Osseointegration Problem1
Patient problems
- No Consequences Or Impact To Patient4
- Device Embedded In Tissue or Plaque2
- Impaired Healing2
- Failure of Implant1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SCREWS REQUIRED REPOSITIONING DUE TO UNKNOWN REASONS. THEY WERE REMOVED AND NEW SCREWS WERE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 23855154 ↗InjuryMay 28, 2021Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS BECAME LOOSE AND WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 11901248 ↗InjurySep 10, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7860243 ↗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 7812532 ↗MalfunctionJun 29, 2018Break; Break
IT WAS REPORTED A SCREW BROKE OFF IN THE PEEK IMPLANT. THE BROKEN PORTION OF THE SCREW LEFT IN THE IMPLANT WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7651585 ↗MalfunctionJun 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT'S X-RAY SHOWED DISPLACED PLATES AND SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7651579 ↗InjuryFeb 13, 2018Fracture; Fracture
SCREW HEAD BROKE OFF DURING IMPLANTATION AND THE SHAFT OF THE SCREW REMAINS IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7267582 ↗InjuryNov 3, 2017Fracture; Fracture
SCREW HEAD BROKE OFF AT THE THREAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6999121 ↗InjuryApr 26, 2017Sticking; Material Integrity Problem
WHEN THE DOCTOR WAS PUTTING THE PLATE ON TO THE SEGMENTALIZED FIBULA BONE AFTER PRE-DRILLING THE HOLES, THE 7 MM SCREWS PARTIALLY THREADED BEFORE BECOMING STUCK IN THE BONE. INCREASED FORCE ON THE SCREWDRIVER TO MOBILIZE SCREWS CAUSED THE SCREW HEADS TO STRIP AND THEY BECAME UNUSABLE. DOCTOR WAS FORCED TO REMOVE THE SCREWS WITH A WIRE-DRIVER, AND ONE OF THE SCREW HEADS BROKE OFF FROM THE THREADS. THE DOCTOR HAD TO MOVE THE PLATE TO A NON-IDEAL LOCATION SLIGHTLY BELOW THE PREVIOUS SCREW HOLES IN ORDER TO FIXATE THE PLATE WHILE AVOIDING THE STRIPPED SCREW BODY. PATIENT IS DOING WELL AND NO OTHER ADVERSE EFFECTS FROM THIS INCIDENT HAVE BEEN REPORTED AT THIS POINT.
Patient problems: Failure of Implant
MAUDE report 6522899 ↗InjuryJan 6, 2017Break
ON (B)(6) 2016 DURING A PROCEDURE TWO MAXDRIVE SCREW HEADS BROKE OFF WHEN PLACED IN THE CRANIUM. REMAINDER OF THE SCREWS WERE LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 6230646 ↗InjuryApr 4, 2016Break
A SCREW HEAD STRIPPED DURING PLACEMENT. THE SCREW REMAINS IN PATIENT'S BONE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5544524 ↗
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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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