ELEVATE™ Spinal System 8881128Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169430846), received between May 31, 2019 and Jan 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) SURGERY FOR DIAGNOSIS OF L4-5 HERNIATED INTERVERTEBRAL DISC (HIVD). IT WAS REPORTED THAT THE SPACER WAS BROKEN. FRAGMENTS OF THE SPACER WERE FOUND. THE FRAGMENTS AND THE CAGE WERE REMOVED AND REPLACED WITH A NEW ONE. THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT SYMPTOMS OR COMPLICATIONS, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109803 ↗
• MalfunctionJan 23, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AND REMOVAL HARDWARE WITH RE-INSTRUMENTATION AT L4/5 DUE TO PSEUDOARTHROSIS, RECURRENT RADICULOPATHY. INTRA-OP, WHEN SURGEON PLACED THE DEVICE IN THE DISC SPACE AND HIT THE INSERTER WITH A MALLET, ON THE THIRD HIT THE SURGEON NOTICED THAT THE DEVICE BROKE AND THEY PULLED THE DEVICE BACK AND OUT OF INCISION. TWO LITTLE PIECES OF PEEK MATERIAL AROUND THE HINGE AREA OF DEVICE WERE BROKEN OFF ON BOTH SIDES OF DEVICE, BOTH PEEK PIECES WERE ACCOUNTED FOR AND THE DEVICE WAS NEVER IMPLANTED INTO THE DISC SPACE. SO, THE DEVICE WAS REPLACED WITH ANOTHER ELEVATE CAGE. THERE WERE NO PATIENT SYMPTOMS AND COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9620860 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L4-S1 DUE TO SPONDY/DEGENERATIVE DISC. INTRA-OP, CAGE WAS BROKEN DURING THE IMPLANTATION. THIS WAS A HYBRID EXPANDABLE IMPLANT WHICH CONTAIN HALF PEEK AND HALF TITANIUM. THE PEEK PORTION WAS REMOVED BUT THE TITANIUM PORTION REMAINED IN THE DISC SPACE. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657159 ↗