Valkyrie Thoracic Fixation System 01-3013-2-HARecalls & reported problems
J.M. Longyear Manufacturing, LLC · HA Screw, Ø3.0 x 13mm (2-pack) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810071390692), received between Sep 27, 2024 and Apr 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Osseointegration Problem1
Patient problems
- Wound Dehiscence2
Recent adverse event reports
The 2 most recent of 2 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 21744996 ↗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 20326489 ↗
Other Screw, Fixation, Bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page