LEVEL ONE THORACICRecalls & reported problems across all models
KLS-Martin L.P. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls
- 0
We found 20 models of LEVEL ONE THORACIC by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between May 3, 2016 and Aug 29, 2025 — classified as 76 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LEVEL ONE THORACIC problems
Device problems
- Break25
- Adverse Event Without Identified Device or Use Problem17
- Osseointegration Problem16
- Fracture9
- Device Dislodged or Dislocated8
- Material Deformation3
- Noise, Audible3
- Loss of Osseointegration2
Patient problems
- Impaired Healing32
- Inadequate Osseointegration12
- No Code Available8
- Pain8
- Nonunion/Delayed-union Bone Fracture6
- Unspecified Infection5
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
LEVEL ONE THORACIC models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE THORACIC 24-025-47-09Plate, fixation, bone9 reports
- LEVEL ONE THORACIC 24-023-13-91Plate, fixation, bone8 reports
- LEVEL ONE THORACIC 24-025-07-09Plate, fixation, bone8 reports
- LEVEL ONE THORACIC 24-023-11-91Plate, fixation, bone7 reports
- LEVEL ONE THORACIC 24-025-50-09Plate, fixation, bone7 reports
- LEVEL ONE THORACIC 24-025-51-09Plate, fixation, bone7 reports
- LEVEL ONE THORACIC 24-025-44-09Plate, fixation, bone5 reports
- LEVEL ONE THORACIC 24-025-49-09Plate, fixation, bone5 reports
- LEVEL ONE THORACIC 24-025-52-09Plate, fixation, bone3 reports
- LEVEL ONE THORACIC 24-015-15-09Plate, fixation, bone3 reports
- LEVEL ONE THORACIC 24-025-57-09Plate, fixation, bone3 reports
- LEVEL ONE THORACIC 24-023-09-91Plate, fixation, bone2 reports
- LEVEL ONE THORACIC 24-023-15-91Plate, fixation, bone2 reports
- LEVEL ONE THORACIC 24-025-42-09Plate, fixation, bone2 reports
- LEVEL ONE THORACIC 24-025-54-09Plate, fixation, bone2 reports
- LEVEL ONE THORACIC 24-023-17-91Plate, fixation, bone1 report
- LEVEL ONE THORACIC 24-025-43-09Plate, fixation, bone1 report
- LEVEL ONE THORACIC 24-025-48-09Plate, fixation, bone1 report
- LEVEL ONE THORACIC 24-015-25-09Plate, fixation, bone1 report
- LEVEL ONE THORACIC 24-016-07-09Plate, fixation, bone1 report
Recent LEVEL ONE THORACIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Fracture; Fracture
ONE OF SIX STERNAL PLATES IMPLANTED INTO MORBIDLY OBESE PATIENT WITH EXTREMELY POOR BONE QUALITY IN OFFLINE STERNOTOMY PROCEDURE FRACTURED SEVEN DAYS AFTER IMPLANT. PHYSICIAN ELECTED TO REMOVE ALL HARDWARE DUE TO PATIENT'S DEGRADING BONE QUALITY. HARDWARE REMOVED WITHOUT INCIDENT.
Patient problems: Insufficient Information
MAUDE report 22926504 ↗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 ↗InjuryJun 25, 2025Fracture; Fracture
IT WAS REPORTED FOLLOWING APPROXIMATELY EIGHT MONTHS OF IMPLANTATION A THORACIC PLATE BECAME FRACTURED. IT WAS IDENTIFIED ON IMAGING AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328336 ↗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 ↗InjuryApr 27, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A STERNAL PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16824400 ↗InjuryJan 5, 2023Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A SCREW BECAME DISLODGED FROM POOR QUALITY BONE DUE TO PATIENT COUGHING. PHYSICIAN ELECTED TO REMOVE HARDWARE FOUR MONTHS LATER AFTER CONSOLIDATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16109534 ↗InjuryOct 27, 2022Fracture; Fracture
SEVEN MONTHS AFTER IMPLANTATION A STERNAL PLATE WAS OBSERVED TO HAVE FRACTURED IN A PATIENT WITH A HISTORY OF POOR OSTEOGENESIS. IT WAS REMOVED AND PATIENT WAS RE-PLATED.
Patient problems: Inadequate Osseointegration
MAUDE report 15685839 ↗InjuryOct 6, 2022Break; Break
IT WAS REPORTED A STERNAL PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15555894 ↗InjurySep 30, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED A SCREW WAS NOT PROPERLY AFFIXED TO PATIENT DURING IMPLANTATION, WHICH NECESSITATED REMOVAL OF THE SCREW.
Patient problems: Insufficient Information
MAUDE report 15509537 ↗InjuryAug 19, 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 15262365 ↗InjuryJul 20, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A STERNAL PLATE BECAME DEFORMED AT A PERSISTENT NON-UNION SITE DUE TO PROBABLE PATIENT NON-COMPLIANCE. IT WAS REMOVED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15069678 ↗InjuryJul 20, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A STERNAL PLATE BECAME DEFORMED AT A PERSISTENT NON-UNION SITE DUE TO PROBABLE PATIENT NON-COMPLIANCE. IT WAS REMOVED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15069523 ↗InjuryJun 15, 2022Off-Label Use; Off-Label Use
IT WAS REPORTED THAT SCREWS IMPLANTED INTO PATIENT'S CARTILAGE IN AN OFF-LABEL APPLICATION DUE TO PATIENT'S POOR BONE QUALITY BECAME LOOSE FROM THE CARTILAGE. THEY WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14700765 ↗InjuryMar 24, 2022Break; Break
IT WAS REPORTED A THORACIC PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 13895115 ↗InjuryMar 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A STERNAL PLATE WAS FOUND DEFORMED ON IMAGING. FIXATED BONE HEALED APPROPRIATELY. PHYSICIAN NOTED DAMAGE TO PLATE MORE THAN LIKELY DUE TO PATIENT NON-COMPLIANCE. THE PLATE WAS REMOVED AFTER PATIENT BEGAN TO COMPLAIN OF DISCOMFORT SEVERAL MONTHS AFTER CONSOLIDATION.
Patient problems: Discomfort
MAUDE report 13671943 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
- LEVEL ONE ORTHOANCHOR15 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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