Valkyrie Thoracic Fixation System 01-020 (UDI 00810071390012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810071390012), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Fracture; Fracture

  IT WAS REPORTED BY A DISTRIBUTOR THAT A VALKYRIE RE OPERATION PROCEDURE OCCURRED IN A PATIENT. THE PATIENT WAS SEEN 11 DAYS POST OPERATIVELY AFTER EXPERIENCING A FALL AND COUGHING FIT. A RE OPERATION WAS INITIATED ON THE PATIENT AND NOTED STERNAL DEHISCENCE WITH THE OBSERVATION OF THE STERNAL CONSTRUCT FAILURE (PULL THROUGH OF WIRES AND FRACTURE OF PLATES). AS A FOLLOW UP, INTERVIEW WITH (B)(6), PA (HCP PRESENT IN THE ORIGINAL AND REVISION CASE) WAS CONDUCTED ON (B)(6) 2023. IT WAS NOTED THAT THE PATIENT'S BONE QUALITY WAS EXTREMELY POOR. THE X-PLATES AND THE V-PLATE FRACTURED AT THE MID-LINE, SCREWS REMAINED ATTACHED TO THE PLATES AND THE BONE. BLUNT FORCE TRAUMA MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE INITIAL CLOSURE OF THE STERNUM, IT WAS NOTED THAT THE STERNUM BONE QUALITY WAS VERY POOR. PATIENT RECEIVED AN ADDITIONAL PROCEDURE TO REMOVE THE DEVICE, A WOUND VAC. AND MUSCLE FLAP WAS PERFORMED.

  Patient problems: Failure of Implant; Wound Dehiscence

  MAUDE report 16483153 ↗