LEVEL ONERecalls & reported problems across all models
KLS-Martin L.P. · 36 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 205
- Deaths reported
- 0
- Injuries reported
- 200
- Recalls
- 0
We found 36 models of LEVEL ONE by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 205 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Aug 13, 2026 — classified as 200 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (157 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 problems
Device problems
- Break157
- Fracture40
- Use of Device Problem11
- Temperature Problem5
- Device Handling Problem3
- Material Fragmentation2
- Difficult to Remove1
- Human-Device Interface Problem1
Patient problems
- Device Embedded In Tissue or Plaque149
- No Consequences Or Impact To Patient36
- No Known Impact Or Consequence To Patient8
- Burn(s)5
- Impaired Healing3
- Foreign Body In Patient1
- Injury1
- Insufficient Information1
LEVEL ONE models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE 25-449-16-91BIT, DRILL35 reports
- LEVEL ONE 25-469-11-07BIT, DRILL33 reports
- LEVEL ONE 25-452-00-91BIT, DRILL30 reports
- LEVEL ONE 25-452-07-91BIT, DRILL25 reports
- LEVEL ONE 25-452-05-91BIT, DRILL10 reports
- LEVEL ONE 01-450-80-07BIT, DRILL9 reports
- LEVEL ONE 25-449-07-91BIT, DRILL8 reports
- LEVEL ONE 25-454-07-91BIT, DRILL7 reports
- LEVEL ONE 01-469-11-07BIT, DRILL5 reports
- LEVEL ONE 25-473-70-07BIT, DRILL4 reports
- LEVEL ONE 25-449-05-91BIT, DRILL3 reports
- LEVEL ONE 25-457-05-91BIT, DRILL3 reports
- LEVEL ONE 25-452-61-07BIT, DRILL2 reports
- LEVEL ONE 25-454-05-91BIT, DRILL2 reports
- LEVEL ONE 25-460-19-07BIT, DRILL2 reports
- LEVEL ONE 25-468-11-04BIT, DRILL2 reports
- LEVEL ONE 25-472-75-07BIT, DRILL2 reports
- LEVEL ONE 25-544-11-07TAP, BONE2 reports
- LEVEL ONE 26-153-11-07BIT, DRILL2 reports
- LEVEL ONE 50-815-05-07BIT, DRILL2 reports
- LEVEL ONE 50-519-16-07BIT, DRILL2 reports
- LEVEL ONE 01-473-70-07BIT, DRILL1 report
- LEVEL ONE 01-473-71-07BIT, DRILL1 report
- LEVEL ONE 25-410-00-07SCREWDRIVER1 report
- LEVEL ONE 25-452-09-91BIT, DRILL1 report
- LEVEL ONE 25-452-15-91BIT, DRILL1 report
- LEVEL ONE 25-452-57-07BIT, DRILL1 report
- LEVEL ONE 25-457-07-91BIT, DRILL1 report
- LEVEL ONE 25-461-16-91BIT, DRILL1 report
- LEVEL ONE 25-473-80-07BIT, DRILL1 report
- LEVEL ONE 26-158-11-07BIT, DRILL1 report
- LEVEL ONE 50-022-15-07BIT, DRILL1 report
- LEVEL ONE 50-515-05-07BIT, DRILL1 report
- LEVEL ONE 50-924-09-07BIT, DRILL1 report
- LEVEL ONE 50-924-16-07BIT, DRILL1 report
- LEVEL ONE 99-595-22-01SCREWDRIVER1 report
Recent LEVEL ONE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Fracture
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50241945 ↗InjuryAug 13, 2026Fracture
It was reported during initial surgery that a twist drill fractured during use. A portion of it remains implanted.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50241942 ↗InjuryJul 7, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25736398 ↗InjuryJun 24, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25610336 ↗InjuryJun 24, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25610331 ↗InjuryJun 5, 2026Fracture
IT WAS REPORTED THAT DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25412669 ↗InjuryApr 30, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25046693 ↗InjuryFeb 10, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24306763 ↗InjuryFeb 10, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24306760 ↗InjuryJan 28, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24203527 ↗InjuryJan 21, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT TWIST DRILLS FRACTURED DURING USE. A PORTION OF THEM REMAIN IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24136427 ↗InjuryDec 16, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF THE TWIST DRILL REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23816662 ↗InjuryDec 10, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23769293 ↗InjuryDec 9, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23760864 ↗InjuryDec 9, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23760863 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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