Cannulated Compression Headless Screw 04.333.124TSRecalls & reported problems
Tyber Medical, LLC · 2.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 24MM · Class 2 · Implant
All models of Cannulated Compression Headless Screw (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00819917027211), received between Jun 27, 2025 and Jun 27, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate3
Patient problems
- Nonunion/Delayed-union Bone Fracture3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: CASE INVOLVES A 12-YEAR-OLD GIRL WITH A PSEUDOARTHROSIS. FORTUNATELY, THE PSEUDOARTHROSIS HAS CONSOLIDATED, SO THE SCREW CAN BE REMOVED IN THE NEAR FUTURE. THE SURGERY TOOK PLACE ON 16/01/25. THE CONTROL PHOTOS HAVE THE DATE VISIBLE, BUT HERE TOO, THERE'S A MORE OR LESS IMMEDIATE FAILURE. THE PSEUDOARTHROSIS HAS CONSOLIDATED, AND THE SCREW WILL BE REMOVED SOON, WITH NO REVISION REQUIRED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350832 ↗MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: PRIMARY FIXATION IN A HEALTHY MAN. SURGERY SCHEDULED ON (B)(6) 2024, PRIMARY FIXATION, WITH ALMOST IMMEDIATE FAILURE. THE PATIENT HAS SINCE THEN UNDERGONE A REVISION WITH A PLATE, BUT THIS TOO HAS FAILED. THE PATIENT IS NOW REFERRED TO A DIFFERENT FACILITY AND OTHER CARE. IMPLANT REVISION SURGERY HAS BEEN REPORTED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350831 ↗MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: THIS SCREW IS EXPECTED TO COME OUT OF THE SCAPHOID IN THE NEAR FUTURE. PSEUDOARTHROSIS IN A LIGHT SMOKER (5 CIGARETTES DAILY) CT REGARDING PSEUDOARTHROSIS CONSOLIDATION ISN'T LOOKING GOOD BASED ON THE IMAGES.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350830 ↗
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.
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