Cannulated Compression Headless Screw 04.333.650Recalls & reported problems
Tyber Medical, LLC · 5.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 50MM · 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 00819917025224), received between Jul 17, 2024 and Jul 17, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Fracture; Fracture
REPORTED FROM CUSTOMER: PROCEDURE: FOOT SURGERY. IT WAS REPORTED THAT ON (B)(6) 2024 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINS OF SURGICAL DELAY. PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THE SCREW WAS BROKEN IN TO 3 PIECES AND 2 OF THE PIECES WERE RETAINED. 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 30 MIN. ACTION TAKEN WHEN EVENT OCCURRED? PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NOT AT THIS TIME. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. TYBER MEDICAL RETRIEVED ADDITIONAL INFORMATION FR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760449 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive 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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