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LEVEL ONE ORTHOANCHOR 01-301-05-09Recalls & reported problems

KLS-Martin L.P. · PLATE, C TUBE, STR, 9 MM BRG, 1.5 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118005809), received between Jul 2, 2021 and Jul 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

  • Break1

Patient problems

  • Impaired Healing1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 2, 2021Break; Break

    IT WAS REPORTED THAT A PLATE BROKE AND IT WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 12111999 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources and updates

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