Valkyrie Thoracic Fixation System 01-020 (UDI 00810071390531)Recalls & reported problems
J.M. Longyear Manufacturing, LLC · X-Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810071390531), received between Aug 8, 2023 and Oct 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO EVIDENCE OF STERNAL INSTABILITY FOLLOWING A SEVERE COUGHING FIT. IT WAS OBSERVED THAT STERNAL WIRES HAD PULLED THROUGH THE BONE AND AN X-PLATE HAD FRACTURED AT A SINGLE LOCATION. IT WAS NOTED THAT THE SCREWS WERE STILL SECURELY LOCKED INTO THE PLATE AS WELL AS FULLY INTACT TO BONE SUBSTRATE. THE DEVICE WAS EXPLANTED, RETAINED BY THE HOSPITAL, AND SENT BACK TO THE MANUFACTURER FOR FURTHER INVESTIGATION. A NEW DEVICE WAS IMPLANTED TO RE-CLOSE THE CHEST-WALL AND THERE WAS NO FURTHER HARM TO THE PATIENT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Wound Dehiscence
MAUDE report 17863579 ↗MalfunctionAug 8, 2023Fracture; Fracture
IT WAS REPORTED THAT AN X-PLATE FRACTURED AROUND A SINGLE SCREW HOLE DURING SCREW INSERTION. IT WAS NOTED THAT THE SCREWS WERE INSERTED MULTIPLE TIMES, THE CADDY GUIDE WAS NOT USED, AND SCREWS WERE INSERTED FREE-HANDED INTO THE CONSTRUCT. THE FRACTURED PLATE WAS REMOVED, AND ANOTHER PLATE WAS IMPLANTED. THERE WAS NO HARM TO THE PATIENT NOR WAS THERE A SIGNIFICANT DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480350 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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