LEVEL ONE THORACIC, STERILE 24-015-26-71Recalls & 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
Quick summary
This KLS-Martin Level One locking rib plate is a titanium plate used to hold ribs or chest bone together with screws. The 27 reports mostly describe the plate breaking or fracturing, sometimes after a fall or crash, and bones healing slowly or not joining back together;24 reports involved injuries and no deaths were reported. Several plates had to be removed and replaced, sometimes where the device was used outside its intended purpose. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888118101440), received between Aug 17, 2017 and Mar 23, 2023 — classified as 24 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (21 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.
Most reported problems
Device problems
- Break21
- Fracture4
- Off-Label Use2
- Osseointegration Problem2
Patient problems
- Impaired Healing17
- Pain4
- Insufficient Information3
- Inadequate Osseointegration2
- No Known Impact Or Consequence To Patient2
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2023Off-Label Use; Off-Label Use
IT WAS REPORTED THAT A PLATE BROKE POSSIBLY DUE TO OFF-LABEL USE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16600154 ↗InjuryAug 19, 2022Off-Label Use; Off-Label Use
IT WAS REPORTED THAT A RIB PLATE BROKE IN AN OFF-LABEL USE WHERE GAP IN PATIENT BONE WAS SPANNED BY PLATE. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 15262341 ↗InjuryJun 2, 2022Fracture; Fracture
IT WAS REPORTED THAT NINE MONTHS AFTER IT WAS IMPLANTED INTO PATIENT, A RIB PLATE WAS FOUND TO HAVE FRACTURED. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 14578714 ↗InjuryJun 1, 2022Break; Break
IT WAS REPORTED THAT TWO THORACIC RIB PLATES BROKE. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 14569565 ↗InjurySep 10, 2021Fracture; Fracture
IT WAS REPORTED THAT A RIB PLATE FRACTURED AFTER RIB CONSOLIDATED AND HEALED. FRACTURED RIB PLATE WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 12455229 ↗InjuryNov 20, 2020Break; Break
PATIENT WITH HIGH BMI, LOW BONE DENSITY AND COPD PRESENTED AFTER REPORTED VEHICLE CRASH WITH BROKEN PLATE. PLATE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 10874470 ↗InjuryNov 12, 2020Break; Break
IT WAS REPORTED THE PATIENT FELL AND BROKE A PLATE. PLATE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10829424 ↗InjuryOct 15, 2020Break; Break
IT WAS REPORTED PLATES BROKE AND WERE REMOVED.
Patient problems: Impaired Healing; Pain
MAUDE report 10683421 ↗InjuryAug 19, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10427540 ↗InjuryJun 19, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10174532 ↗InjuryMay 14, 2020Break; Break
IT WAS REPORTED THAT PLATES BROKE. PATIENT HAS A HISTORY OF NONCOMPLIANCE. THE PLATES WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10058290 ↗InjuryFeb 7, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9682984 ↗InjuryAug 15, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8896914 ↗InjuryMay 23, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE. THE PLATE WAS REMOVED AND REPLACED.
Patient problems: Pain
MAUDE report 8635487 ↗InjuryMay 23, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED ON (B)(6) 2019.
Patient problems: Pain
MAUDE report 8635478 ↗MalfunctionMar 18, 2019Break; Break
IT WAS REPORTED AT A PLATE BROKE. THERE ARE CURRENTLY NO PLANS TO REMOVE IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8428564 ↗InjuryFeb 15, 2019Break; Break
IT WAS REPORTED THAT PLATES BROKE. CURRENTLY THERE ARE NO PLANS TO REMOVE THEM.
Patient problems: Pain
MAUDE report 8344785 ↗InjuryFeb 15, 2019Break; Break
IT WAS REPORTED THAT THE PLATES BROKE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 8344770 ↗MalfunctionFeb 12, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE. CURRENTLY THERE ARE NO PLANS TO REMOVE IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8332122 ↗InjuryJan 22, 2019Break; Break
IT WAS REPORTED THAT THE PLATE BROKE. REMOVAL IS EXPECTED, BUT NO DATE HAS BEEN SET.
Patient problems: Impaired Healing
MAUDE report 8269082 ↗InjuryJan 22, 2019Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8268977 ↗InjuryDec 26, 2018Break; Break
IT WAS REPORTED THAT THE PLATE BROKE. THE PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8196348 ↗InjuryNov 26, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8103551 ↗MalfunctionAug 10, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMAINS IMPLANTED.
Patient problems: Impaired Healing
MAUDE report 7773734 ↗InjuryMay 29, 2018Break; Break
IT WAS REPORTED A PLATE BROKE. THE PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7549132 ↗
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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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