LEVEL ONE THORACIC, STERILE 24-015-32-71Recalls & reported problems
KLS-Martin L.P. · PLATE, RIB, LOCKING, X SHP, SOLID, 2.3 MM SCREW, CP TITANIUM · 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
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888118121264), received between Dec 19, 2019 and Jul 18, 2024 — classified as 13 injuries.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
- Osseointegration Problem1
- Patient-Device Incompatibility1
Patient problems
- Impaired Healing9
- Discomfort1
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2024Break; Break
A THORACIC RIB PLATE SECURING AN UNHEALED RIB WITH A NON-UNION FRACTURED THREE YEARS AFTER IMPLANT. IT WAS REMOVED AND REPLACED IN ORDER TO RE-FIXATE THE RIB FOR PROPER CONSOLIDATION.
Patient problems: Insufficient Information
MAUDE report 19772055 ↗InjuryMar 19, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A RIB PLATE BECAME DEFORMED AFTER SUCCESSFUL CONSOLIDATION OF UNDERLYING BONE. THE PLATE WAS REMOVED DUE TO PATIENT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 13827659 ↗InjuryFeb 1, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE DUE TO NON-COMPLIANCE, AND A PRE-EXISTING CONDITION. IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 13417155 ↗InjurySep 24, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
THORACIC PLATE AFFIXED TO RIB BONE CALLOUSES FRACTURED AFTER PERSISTENT NON-UNION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12527181 ↗InjuryJul 2, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12112001 ↗InjuryJun 18, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT FELL AND THE PLATES BROKE AS A RESULT OF THE FALL AND NECESSITATED REMOVAL OF THE PLATES.
Patient problems: Impaired Healing
MAUDE report 12028686 ↗InjuryDec 10, 2020Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND IS EXPECTED TO BE REMOVED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 10983742 ↗InjurySep 3, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10490921 ↗InjuryMay 28, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. A PORTION REMAINS IMPLANTED. IT WAS REPORTED PLATES ARE BROKEN. PLATES WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10095828 ↗InjuryMar 17, 2020Break; Break
IT WAS REPORTED A PLATE BROKE DUE TO PATIENT'S NONCOMPLIANCE. THE PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9841306 ↗InjuryJan 2, 2020Break; Break
InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing
MAUDE report 9498364 ↗InjuryDec 19, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9498328 ↗
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- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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