LEVEL ONE THORACIC 24-025-51-09Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118031907), received between May 18, 2016 and Aug 29, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
- Fracture3
- Osseointegration Problem2
- Material Deformation1
Patient problems
- Inadequate Osseointegration2
- Foreign Body In Patient1
- Impaired Healing1
- Insufficient Information1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Fracture; Fracture
ONE OF SIX STERNAL PLATES IMPLANTED INTO MORBIDLY OBESE PATIENT WITH EXTREMELY POOR BONE QUALITY IN OFFLINE STERNOTOMY PROCEDURE FRACTURED SEVEN DAYS AFTER IMPLANT. PHYSICIAN ELECTED TO REMOVE ALL HARDWARE DUE TO PATIENT'S DEGRADING BONE QUALITY. HARDWARE REMOVED WITHOUT INCIDENT.
Patient problems: Insufficient Information
MAUDE report 22926504 ↗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 15069678 ↗InjuryDec 29, 2021Break; Break
THE PHYSICIAN REPORTED THAT A STERNAL PLATE BROKE DUE TO PATIENT NON-COMPLIANCE. THE PLATE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13109863 ↗InjurySep 29, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
STERNAL PLATES BROKE AND WAS REMOVED FROM THE PATIENT ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 6905767 ↗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 6671673 ↗InjuryAug 5, 2016Break
A STERNAL PLATE BROKE AFTER IMPLANTATION. THE PATIENT DID NOT UNDERGO A SECONDARY SURGERY. THE PLATE REMAINS IN PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 5849764 ↗InjuryMay 18, 2016Break
TWO STERNAL PLATES BROKE. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REPLACE THE PLATES.
Patient problems: No Code Available
MAUDE report 5662607 ↗
Other Plate, fixation, bone devices
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- 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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