LEVEL ONE NEURORecalls & reported problems across all models
KLS-Martin L.P. · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls
- 0
We found 27 models of LEVEL ONE NEURO by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2016 and Jun 26, 2026 — classified as 62 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LEVEL ONE NEURO problems
Device problems
- Adverse Event Without Identified Device or Use Problem40
- Break12
- Osseointegration Problem4
- Improper or Incorrect Procedure or Method3
- Patient Device Interaction Problem3
- Fracture2
- Device Issue1
- Insufficient Device Problem Information1
Patient problems
- Impaired Healing27
- Unspecified Infection13
- Cerebrospinal Fluid Leakage7
- Device Embedded In Tissue or Plaque3
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Pain2
- Discomfort1
LEVEL ONE NEURO models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE NEURO 99-576-76-01PLATE, BONE9 reports
- LEVEL ONE NEURO 25-010-20-09PLATE, BONE7 reports
- LEVEL ONE NEURO 25-975-04-91Plate, fixation, bone7 reports
- LEVEL ONE NEURO 25-007-11-09PLATE, BONE3 reports
- LEVEL ONE NEURO 25-015-07-09PLATE, BONE3 reports
- LEVEL ONE NEURO 25-322-71-09PLATE, BONE3 reports
- LEVEL ONE NEURO 99-576-76-05PLATE, BONE3 reports
- LEVEL ONE NEURO 25-003-14-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-003-21-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-004-25-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-007-10-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-016-07-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-302-13-09PLATE, BONE2 reports
- LEVEL ONE NEURO 25-975-05-91Plate, fixation, bone2 reports
- LEVEL ONE NEURO 99-576-76-07PLATE, BONE2 reports
- LEVEL ONE NEURO 25-003-04-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-003-17-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-007-14-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-015-05-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-015-09-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-320-71-09PLATE, BONE1 report
- LEVEL ONE NEURO 99-576-76-06PLATE, BONE1 report
- LEVEL ONE NEURO 99-576-76-08PLATE, BONE1 report
- LEVEL ONE NEURO 25-153-06-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-153-07-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-153-08-09PLATE, BONE1 report
- LEVEL ONE NEURO 25-153-14-09PLATE, BONE1 report
Recent LEVEL ONE NEURO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Fracture; Improper or Incorrect Procedure or Method
A NEURO PLATE BECAME FRACTURED DUE TO IMPROPER IMPLANTATION AND USE (SPANNING 1 CM BONE GAP). IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25641231 ↗InjuryMar 5, 2025Break; Break
IT WAS REPORTED PLATES BROKE. THEY WERE REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 21529163 ↗InjuryApr 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A NEURO SCREW WAS FOUND TO BE LOCATED IN THE PATIENT'S SUBDURAL SPACE AND WAS REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 16742113 ↗InjuryJul 16, 2021Break; Break
IT WAS REPORTED THAT THE MESH FRACTURED, AND IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12185060 ↗InjuryMar 30, 2021Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE SCREWS BECAME LOOSE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 11591057 ↗InjuryFeb 24, 2021Osseointegration Problem; Osseointegration Problem
InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PORTION OF THE MESH WAS REMOVED DUE TO THE PATIENT EXPERIENCING DISCOMFORT.
Patient problems: Discomfort
MAUDE report 10943291 ↗InjuryNov 23, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS PULLED FROM THE BONE AND BECAME LOOSE. SCREWS WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10884241 ↗InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE MESH WAS REMOVED DUE TO PATIENT EXPERIENCING PAIN.
Patient problems: Pain
MAUDE report 10874471 ↗InjuryMar 17, 2020Break; Break
InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PLATE, MESH, AND SCREWS BECAME LOOSE AND SHIFTED DUE THE PATIENT BEING PHYSICALLY ASSAULTED; THEREFORE, NECESSITATING THE REMOVAL OF IMPLANTS. PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9574529 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298673 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298671 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298669 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298667 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
- LEVEL ONE ORTHOANCHOR15 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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