LEVEL ONE ORTHOANCHOR 25-301-35-09Recalls & reported problems
KLS-Martin L.P. · PLATE, HOOK, T SHP, LEFT, 6 MM BRG, 1.5 MM SCREW, CP TITANIUM · Class 2 · Implant
All models of LEVEL ONE ORTHOANCHOR (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118037671), received between Aug 17, 2018 and Jan 17, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Off-Label Use1
Patient problems
- Impaired Healing3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2024Off-Label Use; Off-Label Use
AN ORTHOANCHOR PLATE USED IN OFF-LABEL USE BOLLARD TECHNIQUE APPLICATION FRACTURED UNDER LOAD. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18530400 ↗InjuryAug 24, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. THE BROKEN PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7812531 ↗InjuryAug 17, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. AN ATTEMPT TO REMOVE THE PLATE WAS MADE; HOWEVER, IT REMAINS IMPLANTED DUE TO BONE OVERGROWTH.
Patient problems: Impaired Healing
MAUDE report 7793990 ↗
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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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