Cortium Universal OCT Spinal Fixation System UU071-10-3514Recalls & reported problems
Ulrich Medical Usa, Inc. · Screw, Ø 3.5mm, length 14mm, high angulation · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814386026352), received between Oct 24, 2025 and Aug 14, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Detachment of Device or Device Component2
- Mechanical Problem2
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Mechanical Problem; Detachment of Device or Device Component
Tulip disassociated from the polyaxial screw from the polyaxial screw head while the surgeon was implanting it. The screw was removed and replaced without incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255633 ↗InjuryAug 14, 2026Mechanical Problem; Detachment of Device or Device Component
Tulip disassociated from the polyaxial screw from the polyaxial screw head while the surgeon was implanting it. The screw was removed and replaced without incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255328 ↗MalfunctionJan 8, 2026Break
DURING SURGERY THE TULIP HEAD DISSOCIATED FROM THE SCREW TAIL. THE SURGEON WAS WORKING AT THE CERVICAL 4 LEVEL WHEN THEY NOTICED THE SCREWDRIVER WAS STICKING SLIGHTLY AND WHEN IT RELEASED THE TULIP HEAD BECAME DISSOCIATED WITH THE SCREWTAIL. THE SCREW WAS REMOVED AND CAME OUT IN TWO PIECES. THE SCREW WAS REPLACED. ALL PARTS WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 24014861 ↗MalfunctionOct 24, 2025Break; Break
DURING SURGERY THE TULIP HEAD DISSOCIATED FROM THE SCREW TAIL. THE SURGEON DOES NOT TAP THE PREPARATION HOLE PRIOR TO DRIVING THE SCREWS NOR USES THE TISSUE SLEEVE. NOT USING THE TISSUE SLEEVE CAUSED EXCESSIVE PRESSURE TO THE TULIP HEAD WHEN PRESSURE WAS APPLIED TO THE SCREWDRIVER. THIS CAUSED THE TULIP HEAD TO DISSOCIATE FROM THE SCREW TAIL.
Patient problems: Failure of Implant
MAUDE report 23382959 ↗
Other Posterior Cervical Screw System devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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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