ELEVATE™ Spinal System 8881123Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169430808), received between Sep 11, 2018 and May 26, 2020 — 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.

• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT L4-L5 DUE TO SPINAL STENOSIS. INTRA-OP, CAGE WAS FOUND BROKEN WHEN SURGEON INSISTED IN PUTTING IN THE LARGER 11H ELEVATE CAGE. HE TRIED TO INSERT THE IMPLANT AND FOLLOWED UP WITH MULTIPLE HITS FROM A MALLET. THE CAGE WOULDN¿T ADVANCE SO HE TOOK THE IMPLANT OUT AND WAS OBSERVING IT AND PHYSICALLY TOUCHING THE IMPLANT, HE FOUND THAT THE IMPLANT WAS ACTUALLY BROKEN. THE TITANIUM PIECE WAS NOT CONNECTED TO THE PEEK PIECE AT ALL. SO THEY DISCARDED THAT ELEVATE CAGE AND PUT IN THE 10H SIZE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10085838 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT MINIMALLY INVASIVE SURGERY - TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) DUE TO UNKNOWN REASON. INTRA-OP, ELEVATE CAGE BROKE DURING IMPLANTATION. PATIENT COMPLICATIONS WERE UNKNOWN REPORTED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9584703 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MIS TLIF (MINIMALLY-INVASIVE SURGICAL TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY DUE TO DEGENERATIVE DISC. INTRA-OP, PEEK PORTION OF CAGE WAS BROKEN AND WOULD NOT ALLOW US TO FULL SEAT THE IMPLANT IN THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863630 ↗