ELEVATE™ Spinal System 8657007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169432239), received between Jul 27, 2019 and Dec 8, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionDec 8, 2023Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS) VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL SURGERY. IT WAS REPORTED THAT AFTER DISCECTOMY, THE SURGEON USED THE TRAIL TO EXPAND THE DISC SPACE AND CHOOSE THE PROPER SIZE. THE SURGEON EXPANDED TO 11MM SIZE OF TRAIL BUT UNDER X-RAY THE TIP OF TRAIL WASN'T EXPAND TOTALLY AND TAIL OF TRAIL WAS DETACHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289823 ↗
• InjuryJul 27, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION DUE TO SPONDYLOLISTHESIS. INTRA-OP, WHILE USAGE, THE DISTRACTOR INJURED THE DURA. THE DURA WAS SEWN; AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE, THE PATIENT'S ISSUE WAS REPORTED TO HAVE RESOLVED.

  Patient problems: Injury

  MAUDE report 8834434 ↗