LEVEL ONE THORACIC, STERILERecalls & reported problems across all models
KLS-Martin L.P. · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 166
- Deaths reported
- 0
- Injuries reported
- 152
- Recalls
- 0
We found 30 models of LEVEL ONE THORACIC, STERILE by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 166 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2016 and Mar 25, 2026 — classified as 152 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (96 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, STERILE problems
Device problems
- Break96
- Adverse Event Without Identified Device or Use Problem28
- Fracture23
- Osseointegration Problem15
- Use of Device Problem6
- Failure to Osseointegrate5
- Device Markings/Labelling Problem2
- Loss of Osseointegration2
Patient problems
- Impaired Healing98
- Pain17
- Inadequate Osseointegration15
- Insufficient Information11
- No Known Impact Or Consequence To Patient8
- Nonunion/Delayed-union Bone Fracture7
- No Consequences Or Impact To Patient6
- Discomfort5
LEVEL ONE THORACIC, STERILE models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE THORACIC, STERILE 24-015-26-71Plate, fixation, bone27 reports
- LEVEL ONE THORACIC, STERILE 24-015-20-71Plate, fixation, bone23 reports
- LEVEL ONE THORACIC, STERILE 24-015-22-71Plate, fixation, bone22 reports
- LEVEL ONE THORACIC, STERILE 24-015-25-71Plate, fixation, bone18 reports
- LEVEL ONE THORACIC, STERILE 24-015-32-71Plate, fixation, bone13 reports
- LEVEL ONE THORACIC, STERILE 24-016-07-74Plate, fixation, bone8 reports
- LEVEL ONE THORACIC, STERILE 24-015-27-71Plate, fixation, bone7 reports
- LEVEL ONE THORACIC, STERILE 24-016-07-70Plate, fixation, bone7 reports
- LEVEL ONE THORACIC, STERILE 24-015-29-71Plate, fixation, bone6 reports
- LEVEL ONE THORACIC, STERILE 24-009-14-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE4 reports
- LEVEL ONE THORACIC, STERILE 24-009-11-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE3 reports
- LEVEL ONE THORACIC, STERILE 24-009-17-71Plate, fixation, bone3 reports
- LEVEL ONE THORACIC, STERILE 24-026-02-71Plate, fixation, bone3 reports
- LEVEL ONE THORACIC, STERILE 24-015-35-71Plate, fixation, bone2 reports
- LEVEL ONE THORACIC, STERILE 24-015-15-71Plate, fixation, bone2 reports
- LEVEL ONE THORACIC, STERILE 24-015-36-71Plate, fixation, bone2 reports
- LEVEL ONE THORACIC, STERILE 24-015-44-71Plate, fixation, bone2 reports
- LEVEL ONE THORACIC, STERILE 24-039-30-72Plate, fixation, bone2 reports
- LEVEL ONE THORACIC, STERILE 24-008-11-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- LEVEL ONE THORACIC, STERILE 24-008-14-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- LEVEL ONE THORACIC, STERILE 24-010-14-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- LEVEL ONE THORACIC, STERILE 24-010-17-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-010-20-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- LEVEL ONE THORACIC, STERILE 24-011-14-71PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- LEVEL ONE THORACIC, STERILE 24-015-31-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-015-37-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-015-43-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-015-46-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-015-47-71Plate, fixation, bone1 report
- LEVEL ONE THORACIC, STERILE 24-015-38-71Plate, fixation, bone1 report
Recent LEVEL ONE THORACIC, STERILE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Fracture
IT WAS REPORTED THAT A THORACIC PLATE FRACTURED. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686638 ↗InjuryNov 24, 2025Fracture; Fracture
IT WAS REPORTED A PLATE FRACTURED. THE PLATE WAS MODIFIED AND A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 23632723 ↗InjuryAug 8, 2025Fracture; Fracture
IT WAS REPORTED A PLATE FRACTURED. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 22754829 ↗InjuryJul 21, 2025Fracture; Fracture
IT WAS REPORTED FOLLOWING APPROXIMATELY FIFTEEN MONTHS OF IMPLANTATION A THORACIC PLATE BECAME FRACTURED POSSIBLY DUE TO PATIENT CONDITION. A PORTION OF IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 22555407 ↗InjuryJun 4, 2025Fracture; Fracture
IT WAS REPORTED FOLLOWING APPROXIMATELY ONE YEAR OF IMPLANTATION THE THORACIC PLATES BECAME FRACTURED LIKELY DUE TO INITIAL IMPROPER TECHNIQUE. THEY WERE REMOVED AND REPLACED.
Patient problems: Discomfort
MAUDE report 22143791 ↗InjuryJun 4, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
IT WAS REPORTED FOLLOWING APPROXIMATELY ONE YEAR OF IMPLANTATION THE THORACIC PLATES BECAME FRACTURED LIKELY DUE TO INITIAL IMPROPER TECHNIQUE. THEY WERE REMOVED AND REPLACED.
Patient problems: Discomfort; Inadequate Osseointegration
MAUDE report 22143790 ↗InjuryJun 3, 2025Fracture; Fracture
IT WAS REPORTED A THORACIC PLATE BECAME FRACTURED DURING APPROXIMATELY 11 MONTHS OF IMPLANTATION. IT WAS REMOVED AND NO NEW PRODUCTS WERE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133344 ↗InjuryApr 24, 2025Fracture; Fracture
IT WAS REPORTED A PLATE FRACTURED DUE TO THE PLATES INITIAL PLACEMENT OVER INADEQUATE BONE. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 21904045 ↗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 ↗InjuryOct 4, 2024Break; Break
IT WAS REPORTED A THORACIC LOAD-SHARING PLATE FRACTURED 9 MONTHS AFTER IMPLANT SECONDARY TO PATIENT'S FAILED OSTEOTOMY AND NON-UNION AT PLATE FRACTURE SITE. IT WAS REMOVED AND REPLACED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20370042 ↗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 ↗InjuryJul 18, 2024Break; Break
A THORACIC RIB PLATE SECURING AN UNHEALED RIB WITH A NON-UNION FRACTURED THREE YEARS AFTER IMPLANT. IT WAS REMOVED AND REPLACED IN ORDER TO RE-FIXATE THE RIB FOR PROPER CONSOLIDATION.
Patient problems: Insufficient Information
MAUDE report 19772055 ↗InjuryMay 8, 2024Break; Break
IT WAS REPORTED THE THORACIC RECON TALON BROKE DURING USE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 19273562 ↗InjuryMar 1, 2024Break; Break
IT WAS REPORTED A RIB PLATE BROKE. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18815265 ↗InjuryApr 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A Y-SHAPED PLATE BROKE AT OR AFTER IMPLANT AND WAS SUBSEQUENTLY REPLACED.
Patient problems: Insufficient Information
MAUDE report 16824397 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC20 models · 78 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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