Medicrea|UNiD ROD B33126099-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03613720289531), received between Nov 14, 2023 and Mar 6, 2026 — classified as 1 injury, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION THERAPY AT T9 - PELVIS LEVEL. IT WAS REPORTED THAT A ROD FRACTURE OCCURRED AT THE L2-3 LEVEL, AND THE FRACTURED ROD REMAINS IMPLANTED. POSTOPERATIVE X-RAYS WERE CONDUCTED, AND THE ROD FRACTURES WERE IDENTIFIED DURING MEASUREMENT PROTOCOLS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528425 ↗
• MalfunctionSep 8, 2025Break; Device Handling Problem; Break; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. IT WAS REPORTED THAT, THE UNID ROD WAS BROKEN AND THE ROD REMAINS IN PATIENT. LEVELS IMPLANTED WERE T10-ILIAC. THERE WAS NO REVISION SURGERY THAT IS CURRENTLY PLANNED TO EXPLANT THE BROKEN RODS. PATIENT SYMPTOMS WERE ASKED BUT UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990211 ↗
• MalfunctionSep 8, 2025Break; Device Handling Problem; Break; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. IT WAS REPORTED THAT, THE UNID ROD WAS BROKEN AND THE ROD REMAINS IN PATIENT. LEVELS IMPLANTED WERE T10-ILIAC. THERE WAS NO REVISION SURGERY THAT IS CURRENTLY PLANNED TO EXPLANT THE BROKEN RODS. PATIENT SYMPTOMS WERE ASKED BUT UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990184 ↗
• MalfunctionApr 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS USING A SAGITTAL BENDER AT THE TOP OF THE ROD AND THE ROD BROKE WHILE BENDING. 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 19210647 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERWENT POSTERIOR SPINAL FUSION PROCEDURE FOR UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT, INITIALLY THE RODS WERE FRACTURED POST-OPERATIVELY. PROCEDURE OR TECHNIQUE PERFORMED DURING IMPLANTATION WAS POSTERIOR LUMBAR INTERBODY FUSION AT L2-L3, ANTERIOR LUMBAR INTERBODY FUSION AT L5-S1. THE LEVELS IMPLANTED WERE T11-PELVIS. REVISION SURGERY WAS PLANNED FOR (B)(6), 2023. THE INDICATED RODS WERE PARTIALLY REMOVED DURING REVISION. THE RODS WERE CUT ROUGHLY 2 INCHES BELOW THE TOPS TO ACCOMMODATE DOMINOS TO EXTEND THE FUSION CONSTRUCT UP TO T4 FROM T10. IT WAS CONFIRMED THAT THE ORIGINAL RODS WERE NOT FRACTURED BUT THE PATIENT NEEDED TO BE EXTENDED UP. THE CUT OFF ROD PIECES WERE DISPOSED OF. IN POST-OP X-RAYS, THEY DISCOVERED A T10 COMPRESSION FRACTURE WITH BILATERAL PEDICLE FRACTURES WHICH REQUIRED TO EXTEND THE CONSTRUCT TO T4. THERE WERE NO PATIENT SYMPTOMS AS RESULT, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 18128969 ↗