Medicrea|UNiD ROD B33226099-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03613720289739), received between Oct 15, 2024 and Sep 16, 2025 — classified as 1 injury, 3 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.

• MalfunctionSep 16, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT, ROD FRACTURE - RIGHT ROD BETWEEN S1 AND ILIAC SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FUTURE SURGERY DATE SCHEDULED CURRENTLY TO EXPLANT THE FRACTURED ROD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060914 ↗
• MalfunctionJun 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS POSTERIOR FIXATION AND FUSION PROCEDURE, WITH L2/L5 LAMINECTOMY AND L5/S1 TLIF FOR INDICATION OF STENOSIS, BACK PAIN, AND SAGITTAL IMBALANCE. IT WAS REPORTED THAT THE SURGEON WAS BENDING THE UNID ROD WITH IN SITU BENDERS TO SEAT THE ROD INTO A LOWER LUMBAR SCREW, AND ROD BROKE DURING THIS MANEUVER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165067 ↗
• MalfunctionNov 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS SPINAL DEFORMITY. IT WAS REPORTED THAT, THE ROD WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794227 ↗
• InjuryOct 15, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERWENT REVISION SUR GERY. PRE-OP DIAGNOSIS WAS SCOLIOSIS. IT WAS REPORTED THAT, PATIENT HAD INITIAL SURGERY WITH CUSTOM UNID RODS. A COUPLE OF WEEKS LATER, PATIENT CAME BACK WITH THE FEELING THAT SOMETHING HAD POPPED IN HER BACK. PATIENT FELT WHILE SHE WAS WALKING AROUND IN NORMAL LIFE. TOOK X-RAY AND SAW THAT L UNID ROD HAD BROKEN IN CENTER OF TULIP HEAD AROUND L2-L3. REVISION SURGERY WAS PERFORMED AND REMOVED BOTH BROKEN PIECES OF UNID ROD AND REPLACED WITH NEW 6.0 ROD AS WELL AS ADDITIONAL CONSTRUCT PIECES TO STRENGTHEN ENTIRE SEGMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449171 ↗