ELEVATE™ Spinal System 8657005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169432215), received between Aug 28, 2017 and Apr 7, 2021 — classified as 1 injury, 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 16, 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.

• InjuryApr 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING A PROCEDURE OF TRANSFORAMINAL LUMBAR INTERBODY FUSION AT THE LEVELS OF L4-L5 WITH PRE-OPERATIVE DIAGNOSIS OF SPONDYLOLISTHESIS. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN DUE TO FATIGUE FAILURE WHILE IN DISC SPACE. WHILE REMOVING INSTRUMENT, THE DURA WAS TORN (DURAL TEAR). AN ADDITIONAL TREATMENT WAS PERFORMED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE BROKEN INSTRUMENT REMAINED IN PATIENT. THERE WAS A DELAY OF 20 MINUTES OCCURRED TO REPAIR THE DURA. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Spinal Cord Injury

  MAUDE report 11626176 ↗
• MalfunctionAug 28, 2017Break; Break

  PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY. THE DISTRACTOR USED DURING THE SURGERY COLLAPSED TO THE NEUTRAL POSITION AND BROKE INSIDE PATIENT'S DISC SPACE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NO PART OF THE INSTRUMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6823332 ↗