LEVEL ONE THORACIC 24-023-09-91Recalls & 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
- 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 00888118031600), received between May 3, 2016 and Nov 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Installation-Related 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.
Reports received per month
Most reported problems
Device problems
- Installation-Related Problem1
- Loose or Intermittent Connection1
Patient problems
- Inadequate Osseointegration1
- Respiratory Tract Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2024Installation-Related Problem; Installation-Related Problem
THORACIC SCREWS IMPLANTED AGAINST IFUS INTO INTERCOSTAL CARTILAGE BECAME LOOSE AND WERE REMOVED 36 DAYS AFTER IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20619658 ↗InjuryMay 3, 2016Loose or Intermittent Connection
THE SCREWS WERE USED TO FIXATE A PLATE AS A SURGICAL INTERVENTION TO A RIB FRACTURE. THEY WERE REMOVED ON THE FOLLOWING DAY DUE TO PATIENT'S COUGH CAUSING THE SCREWS TO PULL OUT.
Patient problems: Respiratory Tract Infection
MAUDE report 5627215 ↗
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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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