LEVEL ONE THORACIC, STERILE 24-009-14-71Recalls & reported problems
KLS-Martin L.P. · STERNAL TALON, SINGLE FOOT, SMALL, TI-6AL-4V · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118031099), received between Aug 2, 2018 and Jul 9, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem3
- Break1
Patient problems
- Impaired Healing4
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PRODUCT PULLED FROM THE BONE AND WAS REMOVED DUE TO PATIENT NON-COMPLIANCE.
Patient problems: Impaired Healing
MAUDE report 10250307 ↗InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE TALON WAS REMOVED DUE TO A PATIENT COMPLICATION.
Patient problems: Impaired Healing
MAUDE report 9537761 ↗InjuryApr 9, 2019Break; Break
IT WAS REPORTED THAT THE TALON WAS FOUND BROKEN DURING A REVISION SURGERY DUE TO PATIENT CONDITION, STERNAL NON-UNION. THE TALON WAS REMOVED AND REPLACED WITH STERNAL PLATING.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 8496396 ↗InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO THE PATIENT'S CONDITION.
Patient problems: Impaired Healing
MAUDE report 7744248 ↗
Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices
- NA SD800.440Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE22 reports
- AccuShape® MC-SPK30Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- AccuShape® MC-SPK40Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- NA SD800.434Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE11 reports
- NA SD800.427Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- NA SD800.433Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- IPS 60-000-23-09KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
- NA SD800.540Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE6 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.
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