Cannulated Compression Headless Screw 04.333.750Recalls & reported problems
Tyber Medical, LLC · 6.5MM 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 00819917025644), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
- Nonunion/Delayed-union Bone Fracture1
- Radiolucent Lines1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DETAILS FROM CLINICAL STUDY: AT 6 MONTHS POST-OPERATIVE, IT WAS NOTED THAT "SCREW LOOSE; RADIOLUCENCY". THE SUBJECT DID NOT HAVE THE ABILITY TO WALK/PERFORM ACTIVITIES OF DAILY LIVING WITHOUT PAIN. THE SUBJECT WAS INSTRUCTED TO CONTINUE USING THE BONE GROWTH STIMULATOR FOR THE NEXT 6-WEEKS AND RETURN FOR FOLLOW-UP. SUBJECT WAS LOST TO FOLLOW-UP AFTER THE 6-MONTH POST-OPERATIVE VISIT. UNKNOWN IF SUBJECT RETURNED TO NORMAL ACTIVITY OR RECEIVED ADDITIONAL TREATMENT REGARDING THE LUCENCY. AT THE FINAL CLINIC VISIT THE SUBJECT WAS ADVISED TO RESTRICT WEIGHT BEARING AND CONTINUE TO USE BOOT AND CRUTCHES; SUBJECT CANCELLED FOLLOW-UP VISITS. SUBJECT WAS LOST TO FOLLOW-UP AFTER THE 6-MONTH POSTOPERATIVE VISIT. UNKNOWN IF SUBJECT RETURNED TO NORMAL ACTIVITY OR RECEIVED ADDITIONAL TREATMENT.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines
MAUDE report 20493245 ↗
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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