LEVEL ONE THORACIC 24-015-15-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RIB, LOCKING, Z SHP, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118092496), received between Jun 16, 2016 and Dec 6, 2016 — classified as 3 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.
Most reported problems
Device problems
- Break3
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2016Break
THORACIC PLATE BROKE ON RIB SIX. PATIENT WAS NOT EXPERIENCING ANY PAIN OR DISCOMFORT. SURGEON REMOVED THE BROKEN PLATE ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6147207 ↗InjuryOct 4, 2016Break
IMPLANT BROKE AND WAS REMOVED FROM THE PATIENT ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5997719 ↗InjuryJun 16, 2016Break
PLATES WERE BROKEN AFTER PLACEMENT. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REMOVE THEM.
Patient problems: No Code Available
MAUDE report 5730712 ↗
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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