LEVEL ONE THORACIC, STERILE 24-015-22-71Recalls & 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
- 22
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888118101327), received between Jun 19, 2017 and Jun 1, 2022 — classified as 20 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.
Most reported problems
Device problems
- Break17
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Osseointegration Problem3
- Use of Device Problem3
Patient problems
- Impaired Healing11
- No Consequences Or Impact To Patient4
- Inadequate Osseointegration3
- Pain2
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
- Nonunion/Delayed-union Bone Fracture1
- Seizures1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2022Break; Break
IT WAS REPORTED THAT THORACIC RIB PLATES BROKE. THEY WERE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 14569473 ↗InjuryMay 28, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PLATE BROKE DUE TO POSSIBLE PATIENT NONCOMPLIANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 11901244 ↗InjuryJan 20, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11202782 ↗InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PLATE WAS REMOVED DUE TO MALUNION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 11170451 ↗InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT FELL DOWN THE STAIRS AND PLATES BROKE. PLATES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10174536 ↗InjuryMar 26, 2020Break; Break
TREATING PHYSICIAN REPORTED PATIENT FAILED TO COMPLY WITH POST-OPERATIVE INSTRUCTIONS, WAS CONDUCTING HEAVY LIFTING WHEN THE PATIENT HEARD SOMETHING. PATIENT WENT TO THE ER AND AN X-RAY REVEALED THE PLATE HAD BROKEN.
Patient problems: Impaired Healing
MAUDE report 9885076 ↗InjurySep 12, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing; Pain
MAUDE report 9007344 ↗InjuryAug 13, 2019Break; Break
IT WAS REPORTED THAT THE PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8888075 ↗InjuryMar 18, 2019Break; Break
IT WAS REPORTED THAT PLATES BROKE. EXPECTED TO BE REMOVED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 8428563 ↗InjuryFeb 15, 2019Break; Break
IT WAS REPORTED THAT PLATES BROKE. CURRENTLY THERE ARE NO PLANS TO REMOVE THEM.
Patient problems: Pain
MAUDE report 8344781 ↗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 8332126 ↗MalfunctionNov 30, 2018Break; Break
IT WAS REPORTED A PLATE BROKE. CURRENTLY THERE ARE NO PLANES TO REMOVE IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8121225 ↗InjuryNov 30, 2018Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8121220 ↗InjuryNov 5, 2018Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED AND REPLACED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing; Seizures
MAUDE report 8038570 ↗InjuryJul 30, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED A TWIST DRILL BROKE AND WAS REMOVED FROM THE PATIENT. TWIST DRILL WAS BEING USED AT 40,000 RPM. IT IS STATED IN IFU 90-274-92-40 "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7732801 ↗InjuryJul 30, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED A TWIST DRILL BROKE AND CUT THE SURGEON'S FINGER. TWIST DRILL WAS BEING USED AT 40,000 RPM. IT IS STATED IN IFU 90-274-92-40 "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: Laceration(s)
MAUDE report 7732793 ↗InjuryJul 30, 2018Break; Break
IT WAS REPORTED TWO RIB PLATES BROKE IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7732788 ↗InjuryMay 16, 2018Break; Break
IT WAS REPORTED A PLATE BROKE. THE PLATE IS EXPECTED TO BE REMOVED. EXPECTED REMOVAL DATE (B)(6) 2018.
Patient problems: Impaired Healing
MAUDE report 7518471 ↗InjuryMar 2, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT THE PLATE BROKE IN A PATIENT WITH PRE-OPERATIVE BONE SARCOMA. REVIEW OF THE CT SCANS SHOW THAT THE LOWER RIB THAT WAS PLATED WAS NOT REDUCED TO BONE-TO-BONE CONTACT. THE PLATE ON THIS SAME RIB WAS NOT CONTOURED TO ALIGN ON THE RIB COMPLETELY. THIS RESULTED IN SCREWS NOT BEING INSERTED INTO BONE. THE SCREWS THAT WERE INSERTED WERE PLACED IN THE INFERIOR BORDER RESULTING IN SUB-OPTIMAL FIXATION. IFU 90-813-59-10 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 7309538 ↗InjuryDec 11, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
THE RIB PLATE BROKE AFTER IMPLANTATION. THE PLATE WAS EXPLANTED ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 7103790 ↗InjuryAug 17, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
THE RIB PLATE WAS DISCOVERED BROKEN DURING A FOLLOW UP X-RAY. THE PLATE WAS THEN EXPLANTED ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 6801437 ↗InjuryJun 19, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
SALES REPRESENTATIVE RECEIVED THE PATIENT'S SCAN FROM THE DOCTOR SHOWING THE BROKEN RIB PLATES. AT THIS TIME NO OTHER DETAILS ARE KNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 6652141 ↗
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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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