UNiD_PASS B33126012-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03613720269038), received between Apr 6, 2022 and Apr 17, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionApr 17, 2023Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-ILIAC POSTERIOR FUSION AND L2-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION FOR AN INDICATION OF L5-S1 PSEUDOARTHROSIS. IT WAS REPORTED THAT THE UNID RODS IMPLANTED IN 2017 WAS FRACTURED AND THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2023. 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 16749193 ↗
• MalfunctionMay 9, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HAS FRACTURED. 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 14334503 ↗
• MalfunctionApr 8, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HAS FRACTURED. 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 14050486 ↗
• InjuryApr 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGONE T10-PELVIS POSTERIOR SPINAL FUSION WITH ALIFS L4-S1 WITH REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED SPINAL DEFORMITY AND MEDICAL HISTORY INCLUDES SPINAL MALALIGNMENT. IT WAS REPORTED THAT, THE RODS WERE BROKEN. ENTIRE ROD WAS STILL IMPLANTED, SURGEON STATED HE WILL DETERMINE IF HE WILL NEED TO REPLACE THE ROD FOR THE WHOLE FUSION OR DOMINO AROUND THE BREAKAGE AREA DEPENDING ON CT SCAN RESULTS. THE LEVELS IMPLANTED WERE T10-PELVIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14019521 ↗