LEVEL ONE THORACIC 24-023-15-91Recalls & 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 00888118031662), received between Jul 13, 2016 and Sep 3, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Noise, Audible1
- Osseointegration Problem1
Patient problems
- Impaired Healing1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS PULLED FROM THE BONE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10490905 ↗InjuryJul 13, 2016Device Dislodged or Dislocated; Noise, Audible
THE PATIENT MENTIONED TO THE DOCTOR A FEW DAYS POST-OP REGARDING A POPPING SOUND FROM THE IMPLANT SITE ALONG HIS COUGHING FIT. THE SURGEON DISCOVERED ONE OF THE SCREWS THAT WERE STABILIZING THE PLATE WAS DISPLACED. THE SURGEON REPLACED THE IMPLANTS. THIS IS ONE OF THREE INCIDENTS. PLEASE REFER MDR 9610509-2016-00027 AND MDR 9610509-2016-00028.
Patient problems: No Code Available
MAUDE report 5791769 ↗
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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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