LEVEL ONE THORACIC, STERILE 24-015-20-71Recalls & 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 rib plate is a titanium implant used to hold broken ribs together. The 23 reports naming its identifier mostly describe plates breaking after surgery and being removed, often with slow healing and pain, and mention 20 injuries and no deaths. 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
- 23
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888118092526), received between Jul 25, 2017 and Sep 30, 2022 — classified as 20 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
- Osseointegration Problem4
- Fracture3
- Adverse Event Without Identified Device or Use Problem2
- Inadequacy of Device Shape and/or Size1
- Material Deformation1
Patient problems
- Impaired Healing14
- Pain4
- Inadequate Osseointegration3
- Unspecified Infection2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2022Material Deformation; Material Deformation
IT WAS REPORTED A RIB PLATE BROKE. IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 15509491 ↗InjuryDec 29, 2021Break; Break
IT WAS REPORTED THAT A PLATE WAS FOUND BROKEN AFTER CONSOLIDATION. THE PLATE WAS REMOVED.
Patient problems: Pain
MAUDE report 13109963 ↗InjuryMar 30, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
PHYSICIAN REPORTED THAT THE PLATE WAS NOT APPROPRIATE FOR PATIENT OF THIS SIZE.
Patient problems: Impaired Healing
MAUDE report 11591080 ↗InjuryMar 17, 2020Break; Break
IT WAS REPORTED A PLATE BROKE DUE TO PATIENT'S NONCOMPLIANCE. THE PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9841324 ↗InjuryJan 2, 2020Break; Break
IT WAS REPORTED THE PLATE BROKE. IT IS EXPECTED TO BE REMOVED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 9537646 ↗InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing
MAUDE report 9498298 ↗InjuryNov 29, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE DUE TO NON-PRODUCT RELATED TRAUMA, AND WAS REMOVED.
Patient problems: Pain
MAUDE report 9391980 ↗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 9330097 ↗InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 9134138 ↗InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 9134137 ↗InjurySep 26, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMOVED.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 9123933 ↗InjuryAug 30, 2019Break; Break
InjuryJul 26, 2019Break; Break
InjuryMay 23, 2019Break; Break
IT WAS REPORTED THAT THE PLATES BROKE AND WERE REPLACED.
Patient problems: Impaired Healing
MAUDE report 8635481 ↗InjuryDec 7, 2018Break; Break
IT WAS REPORTED THAT THE PLATE BROKE. THE PLATE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8143600 ↗InjurySep 14, 2018Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7877973 ↗MalfunctionAug 13, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND REMAINS IMPLANTED.
Patient problems: Impaired Healing
MAUDE report 7777921 ↗MalfunctionApr 4, 2018Break; Break
IT WAS REPORTED THAT A FOURTH RIB PLATE WAS DISCOVERED BROKEN DURING A FOLLOW-UP X-RAY. PATIENT'S BONES ARE FULLY HEALED. DOCTOR PLANS TO REMOVE THE PLATES DURING THE SUMMER, EXACT DATE FOR REMOVAL IS UNKNOWN AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7397392 ↗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 7272833 ↗InjuryFeb 15, 2018Break; Break
IT WAS REPORTED THAT A RIB PLATE BROKE AND SCREWS BACKED OUT DUE TO NON-UNION OF THE BONE. PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7272824 ↗InjuryNov 29, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
BROKEN PLATE DISCOVERED ON A CT SCAN. THERE IS NO PLAN TO EXPLANT THE BROKEN PLATE AT THIS TIME .
Patient problems: Inadequate Osseointegration
MAUDE report 7067157 ↗InjuryOct 31, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
DURING THE 4 WEEK POST-OPERATIVE FOLLOW-UP DOCTOR NOTICED ON THE POST-OP X-RAY 3 OF THE 6 RIB PLATES IMPLANTED HAD SMALL FRACTURES. THE PLATE FRACTURES ARE AT THE FRACTURE LINE OF THE RIBS. IT IS REPORTED THE DOCTOR IS NOT REMOVING THE PLATES AT THIS TIME.
Patient problems: Inadequate Osseointegration
MAUDE report 6991001 ↗InjuryJul 25, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
TWO WEEKS AFTER THE RIB PLATE WAS IMPLANTED, PATIENT HAD A CHEST X-RAY WHERE DR. (B)(6) NOTICED THE PLATE HAD FRACTURED. IT WAS REPORTED THE PATIENT WAS POTENTIALLY NON-COMPLIANT POST PROCEDURE.
Patient problems: Inadequate Osseointegration
MAUDE report 6740380 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page