Medicrea|UNiD ROD B33225599-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03613720289692), received between Mar 2, 2025 and Dec 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS PROXIMAL JUNCTIONAL KYPHOSIS ABOVE PRIOR FUSION OF L2-S1. IT WAS REPORTED THAT, SURGEON WAS FUSING T10-PELVIS AND NEEDED TO MAKE ADJUSTMENTS TO THE ROD. INTRA OP CORRECTION WASN¿T ACHIEVED AND NEEDED TO MODIFY BEND TO ACCOMMODATE PATIENT SAGITTAL ALIGNMENT. DURING THE BENDING PROCESS, THE ROD SNAPPED HENCE, SURGEON TOOK A NEW STRAIGHT COCR ROD TO BEND FROM SCRATCH. HE ENDED UP IMPLANTING PART OF THIS UNID ROD AS A SATELLITE ROD IN THE OVERALL CONSTRUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836328 ↗
• MalfunctionJul 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A T4-L1 PATIENT HAVING SPINAL TH ERAPY FOR FOR AN INDICATION OF PEDIATRIC DEFORMITY. IT WAS REPORTED THAT THE UNID BROKE INTRA-OPERATIVELY. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT 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 22409519 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION PROCEDURE FROM T3 TO ILIAC. IT WAS REPORTED THAT DURING POST-OPERATIVE MEASUREMENTS, IT WAS NOTICED THAT THE ROD WAS FRACTURED ABOVE ILIAC SCREWS. THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2024 AND PROVIDED POST-OP X-RAYS FOR A CLINIC VISIT ON (B)(6) 2025 WHICH WERE MEASURED ON (B)(6) 2025. THE RODS REMAINED IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22219459 ↗
• MalfunctionMar 2, 2025Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED UNID ROD. PRE-OP DIAGNOSIS OF PATIENT PSF 2 LEVELS ABOVE EXISTING CONSTRUCT. IT WAS REPORTED THAT, LEFT ROD WENT IN FINE, RIGHT ROD BROKE AFTER SURGEON USED IN SITU BENDERS. THERE WAS NO FRAGMENT OF BROKEN ROD LEFT INSIDE PATIENT BODY. THE LEVELS PLANNED FOR IMPLANTATION WERE T2-PELVIS. THE SURGEON BENT THE ROD IN SITU WHICH IS ACTUALLY AGAINST IFU LABELING SO THEY DID NOT USE THE RODS ACCORDING TO IFU LABELING. THERE WAS NO MANUFACTURING ISSUE ASSOCIATED WITH REPORTED UNID ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500909 ↗