DART-FIRE D1N20014SRecalls & reported problems
Wright Medical Technology, Inc. · Headed Compression Screw · Class 2 · Implant
All models of DART-FIRE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840420120328), received between Jun 21, 2021 and Jun 12, 2024 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (4 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
- Difficult to Advance4
- Migration4
- Failure to Advance2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant4
- Bone Fracture(s)2
- Hypersensitivity/Allergic reaction1
- Implant Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT IS HAVING A REACTION TO THE SCREWS THAT WERE IMPLANTED. THE SCREWS "BOTHER HER" AND STILL HURT. THE PATIENT IS HAVING SENSITIVITY TO TOUCH WHERE THE IMPLANTS ARE LOCATED. THE PATIENT MENTIONED THAT THE SCREWS ARE ALSO LOOSENING AND MAY NEED TO HAVE REVISION SURGERY TO REMOVE THE SCREWS.
Patient problems: Hypersensitivity/Allergic reaction; Implant Pain
MAUDE report 19520961 ↗InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038082 ↗InjuryJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038060 ↗InjuryJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038058 ↗MalfunctionJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038046 ↗MalfunctionJun 21, 2021Failure to Advance; Migration; Failure to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038036 ↗InjuryJun 21, 2021Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SCREW WOULD NOT PURCHASE IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. THE PATIENTS BONE CRACKED AND THE SURGERY WAS DELAYED.
Patient problems: Bone Fracture(s)
MAUDE report 12037756 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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