UNiD ROD B33226012-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720269144), received between Mar 27, 2023 and Dec 12, 2023 — classified as 2 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP), DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED UNID RODS. PRE-OP DIAGNOSIS WAS SPINAL STENOSIS. IT WAS REPORTED THAT, THE PATIENT HAD UNKNOWN FLUID COLLECTION SO, REVISION SURGERY WAS PERFORMED. UNID RODS WERE EXPLANTED AND NEW RODS WERE PLACED. THERE WAS NO MALFUNCTION ASSOCIATED WITH REPORTED RODS. THE LEVELS IMPLANTED WERE T10-PELVIS. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Seroma

  MAUDE report 18309510 ↗
• InjuryDec 4, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4-S2AI FUSION FOR AN INDICATION OF T12-L1 PSEUDARTHROSIS. IT WAS REPORTED THAT THE RIGHT UNID ROD IS BROKEN ABOVE THE CORPECTOMY CAGE. THE REVISION SURGERY WILL BE PERFORMED TO REPLACE THE ROD AND REPAIR HIS PRESUMED PSEUDARTHROSIS. 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 18253804 ↗
• MalfunctionMar 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-5 ALIF AND T10 - S2 POSTERIOR SPINAL FUSION FOR AN INDICATION OF SPINAL STENOSIS. THE PATIENT HAD PATIENT MEDICAL HISTORY OF SCOLIOSIS AND DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE ROD BROKE WHILE ATTEMPTING TO IMPLANT THE PATIENT¿S LEFT SIDE DURING A COMPLEX SCOLIOSIS DEFORMITY PROCEDURE. DR. BESS WAS USING IN-SITU BENDERS TO MANIPULATE SHAPE OF ROD TO FIT IN SCREW TULIP HEADS AND ROD BROKE IN TWO PIECES. THE LOWER PORTION OF THE ROD HAD BEEN IMPLANTED AND WAS SECURED WITH SET SCREWS WHEN THE BREAKAGE OCCURRED. THE LOCATION OF THE BREAKAGE WAS NEAR MIDDLE OF THE IMPLANT. ALL ROD FRAGMENTS WERE REMOVED. 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 16617170 ↗