ELEVATE™ Spinal System 7771028Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169430709), received between Sep 26, 2017 and Feb 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS), USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450394 ↗
• MalfunctionOct 27, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN L3-L4 PLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT AFTER REACHING THE TORQUE LIMIT OF THE EXPANDING DRIVER, THE HCP PROCEEDED TO ROTATE THE DRIVER CLOCKWISE, BUT THE DRIVER WAS UNABLE TO ENGAGE IN THE CAGE. THERE WAS NO MALFUNCTION WITH THE SPACER. THE SPACER DID NOT BREAK. THE SCREW THAT EXPANDS THE CAGE BROKE AND THE PIECE WAS RETRIEVED FROM THE PATIENT. THE DRIVER (MDT PRODUCT) WAS NOT AFFECTED. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. THEREWERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702876 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L4-5 DUE TO LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY AND LUMBER SPONDYLOSIS. INTRA-OP, THE CAGE WAS BROKEN DURING INSERTION. THERE WERE NO PATIENT COMPLICATION OCCUR AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10211058 ↗
• MalfunctionSep 26, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR INTER-BODY FUSION. INTRA-OP, CAGE BROKE WHILE THE DOCTOR WAS MALLETING THE IMPLANT INSIDE INTERVERTEBRAL SPACE. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892981 ↗