LEVEL ONE THORACIC, STERILE 24-015-25-71Recalls & reported problems
KLS-Martin L.P. · PLATE, RIB, LOCKING, X SHP, 2.3 MM SCREW, CP TITANIUM · 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
- 18
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888118092540), received between Sep 2, 2016 and Mar 1, 2024 — classified as 16 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (17 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
- Break17
- Fracture1
- Use of Device Problem1
Patient problems
- Impaired Healing12
- No Known Impact Or Consequence To Patient3
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryDec 14, 2022Break; Break
IT WAS REPORTED A THORACIC RIB PLATE BROKE. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 15978853 ↗InjuryOct 14, 2020Break; Break
IT WAS REPORTED PLATES BROKE AND WERE REMOVED.
Patient problems: Impaired Healing; Pain
MAUDE report 10676567 ↗InjuryJul 9, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10255087 ↗InjuryJan 2, 2020Break; Break
IT WAS REPORTED THE PLATES BROKE. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9537654 ↗MalfunctionNov 15, 2019Break; Break
IT WAS REPORTED PLATES BROKE AND REMAINS IMPLANTED. THE PATIENT DECIDED NOT TO HAVE THE PLATES REMOVED AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9330096 ↗InjuryMar 18, 2019Break; Break
IT WAS REPORTED THAT PLATES BROKE. EXPECTED TO BE REMOVED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 8428562 ↗MalfunctionSep 14, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT A PLATE BROKE. THERE ARE NO PLANS TO REMOVE THE PLATE AT THIS TIME. IFU (B)(4) STATES "THE SURGEON MUST ENSURE THE FRACTURED SEGMENTS HAVE BONE TO BONE CONTACT. ANY BRIDGING OF A CONTINUITY DEFECT MUST BE COMBINED WITH A BONE GRAFT".
Patient problems: Impaired Healing
MAUDE report 7877975 ↗InjurySep 10, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMAINS IMPLANTED.
Patient problems: Impaired Healing
MAUDE report 7860232 ↗InjuryAug 13, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMAINS IMPLANTED.
Patient problems: Impaired Healing
MAUDE report 7777915 ↗InjuryAug 8, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMAINS IMPLANTED.
Patient problems: Impaired Healing
MAUDE report 7764734 ↗InjuryJun 29, 2018Break; Break
IT WAS REPORTED THE PLATE BROKE WHILE PATIENT WAS COUGHING.
Patient problems: Impaired Healing
MAUDE report 7651598 ↗InjuryJun 8, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7584213 ↗InjuryFeb 15, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR RIB FRACTURES BUT WAS NON-COMPLIANT WITH POST-OP INSTRUCTIONS. APPROXIMATELY FOUR WEEKS POST-OP, THE PATIENT CHANGED A CAR TIRE. AFTER THIS EVENT, THE PATIENT FELT MOVEMENT AND SOMETHING WRONG IN THE LOCATION OF THE FRACTURES. UPON EXAMINATION, IT WAS DETERMINED THAT BOTH PLATES HAD FRACTURED. IMPLANTS WERE REMOVED, AND RIBS WERE REPAIRED WITH IMPLANTS FROM ANOTHER COMPANY.
Patient problems: Impaired Healing
MAUDE report 7272837 ↗InjuryFeb 15, 2018Break; Break
IT WAS REPORTED THAT A RIB PLATE BROKE. PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7272829 ↗InjuryMar 31, 2017Fracture
RIB PLATE FRACTURED SOMETIME AFTER IMPLANTATION AND WAS REMOVED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6449178 ↗InjuryFeb 16, 2017Break
ONE MONTH POST-OPERATION PATIENT HAD A SCAN AND ALL IMPLANTED PLATES LOOKED FINE. PATIENT CAME BACK TO THE HOSPITAL IN (B)(6) 2016 FOR ANOTHER PROCEDURE AND IT WAS DISCOVERED THAT ONE OF THE PLATES WERE BROKEN. WHILE SHE WAS INPATIENT FOR THE OTHER PROCEDURE THE OTHER TWO PLATES WERE REPORTED TO BREAK. THE BROKEN PLATES WERE REMOVED AND REPLACED ON (B)(6) 2017. IT WAS REPORTED THE PATIENT WAS A SMOKER UP UNTIL THE INITIAL SURGERY.
Patient problems: Failure of Implant
MAUDE report 6335596 ↗InjurySep 2, 2016Break
A PLATE BROKE AFTER IMPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5924979 ↗
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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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