ELEVATE™ Spinal System 7771128Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169430716), received between Mar 2, 2018 and Mar 3, 2021 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 3, 2021Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT 11MM STANDARD ELEVATE CAGE PEEK PORTION CRACKED UPON IMPLANTATION. TI AND PEEK PIECES WERE BOTH EXPLANTED AND REPLACED WITH A 10MM DEVICE WITH NO ISSUES. DEVICE WAS IMPLANTED AND EXPLANTED ON SAME DAY ((B)(6)) 2021). NO DEVICE FRAGMENT LEFT IN PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403297 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE IMPLANT'S PEEK PORTION BROKE OFF FROM TITANIUM PORTION ON IMPLANTATION. THE IMPLANT REMAINS IMPLANTED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908162 ↗
• MalfunctionMar 2, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: DISC HERNIATION TYPE OF PROCEDURE OR TECHNIQUE USED: LUMBAR FUSION LEVELS IMPLANTED: L4-5. IT WAS REPORTED THAT INTRA-OP, CAGE BROKE APART DURING INSERTION. MOST OF THE PEEK PORTION WAS REMOVED. ALL OF THE TI PORTION REMAINS IN THE PATIENT. THERE WERE UNKNOWN AMOUNTS OF PEEK FRAGMENTS REMAINING IN PATIENT. NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310417 ↗