Medicrea|UNiD MIS B33155599-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03613720290094), received between Jan 20, 2026 and Jan 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING AN L2-PELVIS PERCUTANEOUS FIXATION, L2-L4 LATERAL PROCEDURES, AND L4-S1 ANTERIOR LUMBAR INTERBODY FUSIONS (ALIFS) USING THE UNID RODS, THE SCREWS FOR THE UPPER INSTRUMENTED VERTEBRAL BODY PULLED OUT AFTER THE OPERATION. THE SURGEON REQUESTED A LARGE AMOUNT OF CORRECTION TO BE PLANNED IN THE UNID ROD DESIGN PHASE, AND AS THIS WAS THE SURGEON'S FIRST UNID CASE, THE L2 SCREW PULL OUT WAS ATTRIBUTED TO THE USE OF THE RODS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128510 ↗
• InjuryJan 20, 2026Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING AN L2-PELVIS PERCUTANEOUS FIXATION, L2-L4 LATERAL PROCEDURES, AND L4-S1 ANTERIOR LUMBAR INTERBODY FUSIONS (ALIFS) USING THE UNID RODS, THE SCREWS FOR THE UPPER INSTRUMENTED VERTEBRAL BODY PULLED OUT AFTER THE OPERATION. THE SURGEON REQUESTED A LARGE AMOUNT OF CORRECTION TO BE PLANNED IN THE UNID ROD DESIGN PHASE, AND AS THIS WAS THE SURGEON'S FIRST UNID CASE, THE L2 SCREW PULL OUT WAS ATTRIBUTED TO THE USE OF THE RODS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115057 ↗