LEVEL ONE THORACIC 24-025-07-09Recalls & reported problems
KLS-Martin L.P. · PLATE, STERNAL, LOCKING, STR, 2.3 MM SCREW, CP TITANIUM · 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
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118031761), received between Mar 7, 2017 and Jul 20, 2022 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Fracture2
- Osseointegration Problem2
- Material Deformation1
Patient problems
- Impaired Healing4
- Inadequate Osseointegration2
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A STERNAL PLATE BECAME DEFORMED AT A PERSISTENT NON-UNION SITE DUE TO PROBABLE PATIENT NON-COMPLIANCE. IT WAS REMOVED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15069523 ↗InjuryJul 21, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12205840 ↗InjuryMar 17, 2020Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9841346 ↗InjuryJan 2, 2020Break; Break
MalfunctionAug 8, 2018Break; Break
IT WAS REPORTED A PLATE BROKE. REMAINS IMPLANTED WITH NO PLANS TO REMOVE.
Patient problems: Impaired Healing
MAUDE report 7764735 ↗InjurySep 29, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
STERNAL PLATE BROKE AND WAS REMOVED FROM THE PATIENT ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 6905738 ↗InjuryJun 27, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
AFTER THE DOCTOR REVIEWED THE PATIENT'S SCAN IT WAS DETERMINED 3 OF THE 4 STERNAL PLATES IMPLANTED HAVE FRACTURED. THE DOCTOR WILL PERFORM ANOTHER SCAN IN A MONTH AND AT THAT TIME WILL DECIDE WHETHER THE BROKEN PLATES WILL BE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 6671666 ↗InjuryMar 7, 2017Break
TWO 20 HOLE PLATES WERE IMPLANTED INTO THE PATIENT. ONE OF THE PLATES WAS DISCOVERED BROKEN DURING FOLLOW UP. SURGEON DECIDED TO REMOVE BOTH PLATES ON (B)(6) 2017. THESE PLATES WERE THE REPLACEMENT PLATES FROM PREVIOUSLY REPORTED EVENT ON MDR 9610905-2016-00044. SURGEON BELIEVES THAT THERE MAY BE A COMPLIANCE ISSUE WITH THE PATIENT.
Patient problems: No Code Available
MAUDE report 6384747 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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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