Cannulated Screw System + 04.355.885Recalls & reported problems
Tyber Medical, LLC · 7.5MM TI CANN SCREW + FT - 85MM · Class 2 · Implant
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 00810040681196), received between Mar 25, 2024 and Mar 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Separation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Material Separation; Compatibility Problem; Loosening of Implant Not Related to Bone-Ingrowth; Material Separation; Compatibility Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS HARDWARE REMOVAL OCCURRED. THE CANNULATED SCREWS WERE REMOVED BECAUSE THEY BROKE AND PATIENT WAS REVISED TO A HEMIARTHROPLASTY. HARDWARE REMOVAL. CANNULATED SCREWS REMOVED BECAUSE THEY BROKE AND PATIENT WAS REVISED TO A HEMIARTHROPLASTY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. WAS DEVICE EXPLANTED? FALSE. DID PATIENT REQUIRE REVISION SURGERY? FALSE. PATIENT STATUS, OUTCOME , CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS. ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18970182 ↗
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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