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LEVEL ONE THORACIC, STERILE 24-039-30-72Recalls & reported problems

KLS-Martin L.P. · PLATE, STERNAL, LSS, STR, 2.3 MM SCREW, PEEK · Class 2 · Implant

All models of LEVEL ONE THORACIC, STERILE (30)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888118097924), received between Mar 9, 2018 and Jan 22, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Use of Device Problem1

Patient problems

  • Impaired Healing2
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 22, 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: Impaired Healing

    MAUDE report 8268877 ↗
  • InjuryMar 9, 2018Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT THE PATIENT HAD AN OFF MID-LINE STERNOTOMY IN WHICH THE RIBS WERE SEPARATED FROM THE STERNUM AT THE COASTAL CONDYLAR CARTILAGE. THE DOCTOR FIXATED THE LSS PLATES TO THE RIBS IN A VERTICAL FASHION, WHICH IS NOT THE METHOD FOR WHICH THEY ARE INDICATED. IFU STATES "PLATES ARE NOT DESIGNED FOR TRANSVERSE FRACTURE FIXATION, RIB-TO-RIB FIXATION, OR THE SPANNING OF CONTINUITY DEFECTS." ACCORDING TO THE DOCTOR THE LOWER PORTION OF THE PLATE PLACED ON THE RIBS WAS REMOVED DUE TO A PATIENT INFECTION UNRELATED TO THE PRODUCT.

    Patient problems: Impaired Healing; Patient Problem/Medical Problem

    MAUDE report 7327265 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page