ELEVATE™ Spinal System 7770828Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169430648), received between Sep 26, 2018 and Aug 11, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WAS BROKEN AFTER IMPLANTING. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THERAPY INVOLVED IS TLIF- TRANSFORAMINAL LUMBAR INTERBODY FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768822 ↗
• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT SHEERED OFF ELEVATE SCREW. THE SHEERED OFF PIECE OF SCREW WAS LOST AFTER THE CASE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502755 ↗
• MalfunctionJun 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT CAGE SPLIT IN HALF DURING INSERTION AND THE PEEK HALF BECAME DETACHED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND HENCE NO REVISION SURGERY IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840016 ↗
• MalfunctionDec 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE PEEK PORTION OF THE INTERBODY DETACHED WHEN THE SURGEON TRIED TO IMPLANT IT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT BODY. PRODUCT CAME IN CONTACT WITH THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958144 ↗
• MalfunctionSep 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L5/S1 DUE TO DISC HERNIATION. INTRA-OP, DURING IMPLANTATION, THE PEEK PORTION OF THE CAGE BROKE OFF. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909154 ↗