LEVEL ONE THORACIC 24-025-50-09Recalls & 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 00888118031891), received between May 3, 2016 and Jul 21, 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
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Impaired Healing2
- Cancer1
- Failure of Implant1
- Inadequate Osseointegration1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2025Osseointegration Problem; Osseointegration Problem
STERNAL PLATE SEPARATED AFTER IMPLANT AT UNCONSOLIDATED OSTEOTOMY SITE IN 63 YEAR OLD OBESE CANCER PATIENT. IT WAS REMOVED AND REPLACED 8 MONTHS AFTER IMPLANT.
Patient problems: Cancer
MAUDE report 22560500 ↗InjuryDec 29, 2021Break; Break
IT WAS REPORTED A STERNAL PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13111284 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A CP TITANIUM PLATE WAS REMOVED DUE TO AN APPARENT SURGICAL SITE INFECTION UNRELATED TO THE IMPLANT.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 9386352 ↗InjurySep 29, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
STERNAL PLATE BROKE AND WAS REMOVED FROM THE PATIENT ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 6905740 ↗InjuryJan 6, 2017Break
PATIENT'S THORACIC PLATE BROKE NEAR THE XIPHOID AND WAS EXPLANTED. THE OTHER IMPLANTED PLATES REMAINED INTACT AND ALLOWED FOR HEALING. PATIENT PRESENTED CO PAIN AND RUBBING.
Patient problems: Failure of Implant; Pain
MAUDE report 6230672 ↗InjuryMay 18, 2016Break
A STERNAL PLATE BROKE. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REPLACE THE PLATE.
Patient problems: No Code Available
MAUDE report 5662624 ↗InjuryMay 3, 2016Device Dislodged or Dislocated
A PLATE WAS IMPLANTED AS A SURGICAL INTERVENTION TO A RIB FRACTURE. THE PLATE WAS REMOVED ON THE FOLLOWING DAY DUE TO PATIENT'S COUGH CAUSING THE SCREWS TO PULL OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5627214 ↗
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- 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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