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LEVEL ONE THORACIC 24-023-13-91Recalls & reported problems

KLS-Martin L.P. · SCREW, STERNAL, MAXDRIVE, LOCKING, DRILL FREE, TI-6AL-4V · Class 2 · Implant

All models of LEVEL ONE THORACIC (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118031648), received between Nov 13, 2018 and Jan 5, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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.

Most reported problems

Device problems

  • Osseointegration Problem3
  • Adverse Event Without Identified Device or Use Problem2
  • Loss of Osseointegration2
  • Use of Device Problem1

Patient problems

  • Impaired Healing6
  • Inadequate Osseointegration1
  • Insufficient Information1
  • Nonunion/Delayed-union Bone Fracture1
  • Pain1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 5, 2023Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED THAT A SCREW BECAME DISLODGED FROM POOR QUALITY BONE DUE TO PATIENT COUGHING. PHYSICIAN ELECTED TO REMOVE HARDWARE FOUR MONTHS LATER AFTER CONSOLIDATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 16109534 ↗
  • InjurySep 30, 2022Use of Device Problem; Use of Device Problem

    IT WAS REPORTED A SCREW WAS NOT PROPERLY AFFIXED TO PATIENT DURING IMPLANTATION, WHICH NECESSITATED REMOVAL OF THE SCREW.

    Patient problems: Insufficient Information

    MAUDE report 15509537 ↗
  • InjuryDec 14, 2021Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED SCREWS PULLED LOOSE DUE TO PATIENT NEGLIGENCE AND NON-COMPLIANCE WHICH NECESSITATED REMOVAL OF THE SCREWS.

    Patient problems: Impaired Healing

    MAUDE report 13001404 ↗
  • InjuryFeb 19, 2020Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED LOOSE SCREWS WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 9726394 ↗
  • InjuryJul 1, 2019Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT THE SCREWS BECAME LOOSE AND WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 8750428 ↗
  • InjuryJun 24, 2019Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THE SCREWS BECAME LOOSE. THEY WERE REMOVED AND REPLACED.

    Patient problems: Impaired Healing

    MAUDE report 8728523 ↗
  • InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED DEVICE WAS REMOVED DUE TO PATIENT CONDITION.

    Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture; Pain

    MAUDE report 8604924 ↗
  • InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

    Patient problems: Impaired Healing

    MAUDE report 8063808 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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