LEVEL ONE CMF 25-872-13-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, 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
- 15
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888118046796), received between Oct 11, 2017 and Nov 22, 2023 — classified as 14 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break9
- Osseointegration Problem3
- Fracture1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Device Embedded In Tissue or Plaque7
- Impaired Healing3
- No Consequences Or Impact To Patient3
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2023Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED POSITIONAL SCREWS USED IN A REVISION PROCEDURE BECAME LOOSE FROM PATIENT'S COMPROMISED BONE. THEY WERE REMOVED AND REPLACED WITH AN ALTERNATIVE FIXATION DEVICE FIXATED TO DIFFERENT LOCATIONS IN PATIENT'S BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 18194135 ↗InjuryDec 22, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
TWO POSITIONAL FIXATION SCREWS FIXATING A BILATERAL SAGITTAL SPLIT OSTEOTOMY BECAME LOOSE DUE TO PATIENT INVOLVEMENT. THEY WERE REPLACED WITH A PLATE AND FOUR SCREWS.
Patient problems: Insufficient Information
MAUDE report 16040525 ↗InjuryMar 8, 2019Break; Break
IT WAS REPORTED THE SCREW BROKE AND A PORTION REMAINS IMPLANTED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8404267 ↗InjuryMar 8, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE SCREWS WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8404206 ↗InjuryMar 8, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE SCREWS WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8404191 ↗MalfunctionFeb 27, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8375621 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8298209 ↗InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE SCREW WILL BE REMOVED (B)(6) 2019 FOR UNKNOWN REASONS. FOLLOW UP ATTEMPTS HAVE BEEN MADE.
Patient problems: Impaired Healing
MAUDE report 8196340 ↗InjuryDec 3, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. ALL PIECES REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8126157 ↗InjuryNov 13, 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 8063796 ↗InjuryOct 29, 2018Break; Break
SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8016670 ↗InjuryAug 17, 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 7794013 ↗InjuryAug 13, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING USE AND A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7777924 ↗InjuryJun 8, 2018Break; Break
IT WAS REPORTED A SCREW BROKE AND PART OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7584256 ↗InjuryOct 11, 2017Fracture; Fracture
SCREW HEAD SEPARATED DURING IMPLANTATION FROM SHEAR. REMAINING BODY OF SCREW WAS REMOVED FROM PATIENT AND DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6941164 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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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