LEVEL ONE CMF 25-872-11-91Recalls & 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
- 14
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888118046772), received between Feb 16, 2017 and Nov 22, 2023 — classified as 13 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Osseointegration Problem3
- Adverse Event Without Identified Device or Use Problem2
- Component Falling1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- Impaired Healing4
- Device Embedded In Tissue or Plaque3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- Inadequate Osseointegration1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 14 most recent of 14 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 18194124 ↗InjuryNov 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT POSITIONAL SCREWS BECAME LOOSE DURING EXTUBATION OF PATIENT AND WERE REPLACED WITH NEW SCREWS.
Patient problems: Impaired Healing
MAUDE report 15852886 ↗InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED A SCREW BECAME LOOSE DUE TO PATIENT NON-COMPLIANCE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 10829427 ↗InjuryApr 16, 2019Break; Break
IT WAS REPORTED A SCREW HEAD BROKE OFF AND A PORTION OF THE SCREW REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8518283 ↗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 8404203 ↗MalfunctionJan 22, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A SCREW BENT. ALL PIECES WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8268984 ↗InjuryDec 26, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; 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; No Consequences Or Impact To Patient
MAUDE report 8196345 ↗InjuryNov 30, 2018Break; Break
IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8121217 ↗InjurySep 24, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901651 ↗InjuryAug 24, 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 7812530 ↗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 7794005 ↗InjuryJul 20, 2018Break; Break
IT WAS REPORTED A SCREW HEAD BROKE OFF DURING IMPLANTATION AND THE SHAFT OF THE SCREW REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7706949 ↗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 7651572 ↗InjuryFeb 16, 2017Break; Component Falling
DURING IMPLANTATION OF THE SCREW THE HEAD OF THE SCREW BROKE OFF. DOCTOR ATTEMPTED TO REMOVE THE SCREW BUT WITH NO SUCCESS. DOCTOR CHOSE TO LEAVE THE SCREW IN THE PATIENT. THE SCREW WAS 9/10 OF THE WAY IN AND WAS FLUSH WITH THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 6335646 ↗
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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