ELEVATE™ Spinal System 8881028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169430839), received between Jan 9, 2024 and Jun 3, 2024 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Break; Activation Problem; Break; Activation Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L4-5 TLIF FOR UNKNOWN I NDICATION. IT WAS REPORTED THAT AFTER USING ELEVATE'S DISTRACTOR AND CHOOSING APPROPRIATE SIZE OF IMPLANT. THE SURGEON INSERTED THE PROSTHESIS AND EXPANDED THE IMPLANT. THE SURGEON FELT THE CAGE WASN'T EXPANDING THEN HE COLLAPSED THE CAGE AND REMOVED THE CAGE. THE CAGE IS BROKEN. THE SURGEON REPLACED WITH THE SAME SIZE OF CAGE AND FINISHED THE SURGERY.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448119 ↗
• MalfunctionJan 9, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE DEVICE DID NOT EXPAND. UPON INSPECTION OF THE IMPLANT IT WAS FOUND THAT THE IMPLANT WAS BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473006 ↗