UNiD ROD B33126012-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03613720268970), received between Jan 5, 2022 and Jun 26, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE UNID ROD WAS FRACTURED. POSTOPERATIVE X-RAYS WERE MEASURED AND FOUND THAT THE ROD WAS FRACTURED IN LUMBAR LEVEL. PROCEDURE PERFORMED WAS POSTERIOR SPINAL FUSION. LEVELS IMPLANTED WERE T4-ILIAC BONE. IT WAS UNKNOWN ABOUT THE PATIENT SYMPTOMS OR COMPLICATIONS. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334779 ↗
• MalfunctionJul 17, 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, ROD BREAKAGE SEEN IN POSTOP IMAGING. THE LEVELS IMPLANTED WERE L1-S1. PROCEDURE/TECHNIQUE PERFORMED WAS POSTERIOR SPINAL FUSION. 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 19760044 ↗
• MalfunctionJul 15, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE RODS WERE NOTICED BROKEN JUST ABOVE THE L3 PEDICLE SCREW ON A POST-OPERATIVE X-RAY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739121 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPO RTED PRODUCT. IT WAS REPORTED, A ROD WAS INVOLVED IN THE EVENT. PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2016 FROM T10-PELVIS. POSTOP IMAGES WERE ACQUIRED AT FOLLOW UP'S DOES NOT SHOW A ROD FRACTURE. PATIENT UNDERWENT ANOTHER UNID SURGERY ON (B)(6) 2019 AND THAT ROD WENT FROM T5-T9/T10. POSTOP IMAGE ACQUIRED AT (B)(6) 2019 AND MEASURED IN (B)(6) 2022 SHOWED A ROD FRACTURE AT S1. A POST-OP IMAGE TAKEN ON (B)(6) 2022 SHOWS THE FRACTURED ROD STILL REMAINS IN PATIENT. THERE WAS NO FURTHER INFORMATION MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649041 ↗
• MalfunctionJun 6, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS POST ERIOR FUSION. IT WAS REPORTED THAT IT WAS NOTICED THAT THE ROD HAS FRACTURED WHEN COMPLETING POST-OPERATIVE MEASUREMENTS. 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 14600385 ↗
• InjuryJan 5, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4 - L1 PEDIATRIC ORTHOPEDIC SURGERY FOR AN INDICATION OF ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). IT WAS REPORTED THAT THE ROD HAS FRACTURED AND CURRENTLY REMAINS IN THE PATIENT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017 AND THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2021. AN ADDITIONAL SATELLITE ROD WAS CONNECTED VIA DOMINOS TO THE FRACTURED ROD. NO NEED FOR ANY REMOVAL PER SURGEON. 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 13164450 ↗