Cannulated Compression Headless Screw 04.334.660Recalls & reported problems
Tyber Medical, LLC · 5.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 60MM · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917025491), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Fracture; Fracture
JOINT FUSION/ARTHRODESIS OF THE INTERMEDIATE TALUS ON THE LEFT SIDE USING A 5.5MM HEADLESS TITANIUM SCREW 55MM LONG (WITH LONG THREAD), A 5.5MM HEADLESS TITANIUM SCREW 60MM LONG (WITH LONG THREAD), A 6.5MM HEADLESS TITANIUM SCREW 100MM LONG (WITH SHORT THREAD) AND A 7.5MM HEADLESS TITANIUM SCREW 90MM LONG (WITH SHORT THREAD) WITH PROTEIOS NON-STRUCTURAL ALLOGRAFT. PATIENT HAD SEVERE DEFORMITY THAT REQUIRED A COMPLICATED TREATMENT. THE TREATMENT RESULTED IN A PSEUDARTHROSIS/NONUNION WITH SCREW BREAKAGE (THE TWO 5.5MM DIAMETER SCREWS) THAT REQUIRED REVISION BY A TIBIAL CALCANEAL FUSION WITH A NAIL. THE TWO INTACT SCREWS WERE REMOVED, BUT THE BROKEN SCREWS WERE LEFT IN THE PATIENT DUE TO THE DIFFICULTY OF REMOVING THEM, AND PER THE SURGEON WERE NOT REQUIRED TO BE REMOVED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 11391969 ↗
Other Screw, fixation, bone devices
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- 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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