Medicrea|UNiD OCT B33243699-01Recalls & reported problems
Medicrea International · UNID EXP B33243699-01 DUAL 3.5/6.0 CC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720290018), received between Mar 1, 2025 and May 12, 2026 — classified as 3 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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING INTRAOPERATIVE REVISION PROCEDURE FOR PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT THE UNID ROD WAS BEING PLACED INTO THE TULIP HEADS, THE ROD SNAPPED AND SHEARED AT THE 6.0 DIAMETER PORTION. THE ROD WAS TAKEN OUT AND REPLACED WITH A NEW ROD, AND NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148734 ↗MalfunctionMar 11, 2026Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, POSTOPERATIVE X-RAYS FOR PATIENT CLINIC VISIT ON (B)(6) 2025 WERE MEASURED AND NOTICED THE ROD FRACTURES DURING MEASUREMENT PROTOCOLS. LEVELS IMPLANTED WERE C2-S2A1. PROCEDURE PERFORMED WAS POSTERIOR SPINAL FUSION. IT WAS UNKNOWN IF THERE WERE ANY COMPLICATIONS OR ADDITIONAL HOSPITALIZATION OR SURGERY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567570 ↗MalfunctionMar 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR CERVICAL DEFORMITY. IT WAS REPORTED THAT, ROD BROKE AT TRANSITION POINT WHEN SURGEON TRIED TO ADD MORE LORDOSIS TO THE CERVICAL PORTION OF ROD. THERE WERE NO BROKEN FRAGMENTS OF THE ROD LEFT INSIDE THE PATIENT BODY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION. NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21500880 ↗
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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