LEVEL ONE THORACIC, STERILE 24-016-07-70Recalls & reported problems
KLS-Martin L.P. · SCREW, RIB, MAXDRIVE, LOCKING, DRILL FREE, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE THORACIC, STERILE (30)
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 10888118101928), received between Jan 12, 2018 and Nov 13, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Adverse Event Without Identified Device or Use Problem4
- Osseointegration Problem3
Patient problems
- Pain3
- Inadequate Osseointegration2
- Impaired Healing1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
10 MONTHS AFTER IMPLANT THORACIC FIXATION SCREWS WERE REMOVED FROM CONSOLIDATED AND HEALED BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 20678062 ↗InjuryAug 6, 2024Osseointegration Problem; Osseointegration Problem
THORACIC SCREWS BECAME SLIGHTLY LOOSENED FROM MULTIPLE BONES IN THE SAME LOCATION DUE TO UNKNOWN REASONS. THEY WERE REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19916973 ↗InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SCREW PULLED FROM THE BONE OF OBESE PATIENT. IT WAS REMOVED. DOCTOR DOES NOT BELIEVE IT WAS HARDWARE ISSUE.
Patient problems: Insufficient Information
MAUDE report 15245772 ↗InjuryMay 29, 2020Osseointegration Problem; Osseointegration Problem
InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing
MAUDE report 9498349 ↗InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED SCREWS WERE REMOVED DUE TO THE PATIENT'S COMPLAINT OF PAIN UNRELATED TO THE IMPLANTS.
Patient problems: Pain
MAUDE report 9400829 ↗InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED AN ADDITIONAL SURGERY TO REMOVE A SCREW IN AN AREA OF REPORTED PAIN. PHYSICIAN DETERMINED THE PAIN IS UNRELATED TO THE SCREW. NO KNOWN DEIVCE PROBLEM WITH SCREW.
Patient problems: Pain
MAUDE report 7187609 ↗
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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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