Valkyrie Thoracic Fixation System 01-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810071390593), received between Sep 27, 2024 and Apr 1, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD UNDERGONE OPEN HEART SURGERY IN (B)(6) 2025 HAD A REOPERATION IN (B)(6) 2025 DUE TO A STERNAL DEHISCENCE IN WHICH A GAP WAS IDENTIFIED. UPON REOPERATION, IT WAS OBSERVED THAT THE PLATES AND SCREWS DISASSOCIATED FROM THE BONE ON ONE SIDE OF THE OSTEOTOMY. IT WAS NOTED THAT THE STERNAL WIRES ALSO PULLED THROUGH THE STERNUM. THE PLATE DID NOT FRACTURE, THE SCREWS WERE STILL SECURED INTO THE PLATE, AND THE PLATE REMAINED AFFIXED TO ONE SIDE OF THE OSTEOTOMY. THE PREVIOUS STITCHES, WIRES, AND PLATES AND SCREWS WERE REMOVED AND DISCARDED. ADDITIONAL PLATES AND A SUPPLEMENTAL CIRCUMFERENTIAL DEVICE WERE IMPLANTED TO APPROXIMATE AND STABILIZE THE STERNUM. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Wound Dehiscence

  MAUDE report 21744894 ↗
• InjuryApr 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD UNDERGONE OPEN HEART SURGERY IN (B)(6) 2024 HAD A REOPERATION IN (B)(6) 2025 DUE TO A STERNAL DEHISCENCE IN WHICH A GAP WAS IDENTIFIED IN THE BOTTOM THIRD OF THE STERNUM. UPON REOPERATION, IT WAS OBSERVED THAT A SINGLE PLATE AND SCREWS DISASSOCIATED FROM THE BONE ON ONE SIDE OF THE OSTEOTOMY. IT WAS NOTED THAT STERNAL WIRES ALSO PULLED THROUGH THE STERNUM. THE PLATE DID NOT FRACTURE, THE SCREWS WERE STILL SECURED INTO THE PLATE, AND THE PLATE REMAINED AFFIXED TO ONE SIDE OF THE OSTEOTOMY. THE SURGEON DID NOT EXPLANT THE SUBJECT DEVICE(S) NOR WAS THE STERNUM RE-APPROXIMATED. ADDITIONAL PLATES AND A SUPPLEMENTAL CIRCUMFERENTIAL DEVICE WERE IMPLANTED TO STABILIZE THE STERNUM.

  Patient problems: Wound Dehiscence

  MAUDE report 21740893 ↗
• InjurySep 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT STERNAL CLOSURE USING A VARIETY OF PLATES AND SCREWS ALONG WITH STAINLESS-STEEL SUTURE IN (B)(6) 2024 EXPERIENCED A STERNAL DEHISCENCE AFTER AN EXTREME COUGHING FIT. IT WAS ALSO REPORTED THAT THE PLATES AND SCREW CONSTRUCT REMAINED INTACT, BUT PULLED AWAY FROM BONE, AND THE STAINLESS-STEEL SUTURE PULLED THROUGH THE STERNAL TISSUE. THE PATIENT UNDERWENT REVISION SURGERY TO CORRECT THE DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 20324268 ↗