ELEVATE™ Spinal System 8880928Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169430822), received between Jan 24, 2017 and Jul 28, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING A L4-5 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH HIVD. IT WAS REPORTED THAT WHEN SURGEON INSERTED THE CAGE INTO L4-5 DISC AND THE CAGE WAS BROKEN. SURGEON REMOVED THE CAGE COMPLETELY AND REPLACED THE NEW ONE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629684 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DOCTOR STATED THE ELEVATE IMPLANT WAS LOOSE ONCE LOADED ON THE INSERTER HANDLE. A SECOND IMPLANT WAS IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583509 ↗
• MalfunctionOct 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. IT WAS REPORTED THAT THE CAGES WERE BROKEN. AFTER THE SURGEON INSERTED THE TRAIL AND CHOSE THE APPROPRIATE SIZE OF IMPLANT, HE INSERTED THE IMPLANT AND TRIED TO EXPAND THE CAGE. HE CHECKED THE C-ARM AND SAW THE IMPLANTED WAS BROKEN THEN HE REMOVED THE IMPLANT AND REPLACED THE NEW ONE. AND THE SAME SITUATION OCCURRED. HE TRIED TO INSERT THE THIRD IMPLANT AND SUCCEED. HE FINALLY FINISHED THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437233 ↗
• MalfunctionOct 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. IT WAS REPORTED THAT THE CAGES WERE BROKEN. AFTER THE SURGEON INSERTED THE TRAIL AND CHOSE THE APPROPRIATE SIZE OF IMPLANT, HE INSERTED THE IMPLANT AND TRIED TO EXPAND THE CAGE. HE CHECKED THE C-ARM AND SAW THE IMPLANTED WAS BROKEN THEN HE REMOVED THE IMPLANT AND REPLACED THE NEW ONE. AND THE SAME SITUATION OCCURRED. HE TRIED TO INSERT THE THIRD IMPLANT AND SUCCEED. HE FINALLY FINISHED THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437190 ↗
• MalfunctionDec 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT A SMALL PIECE OF PEEK INSIDE THE ELEVATE GRAFT AREA SNAPPED OFF DURING INSERTION OF THE CAGE AND IT WAS DISCOVERED TO BE PART OF THE ELEVATE SPACER. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. PATIENT MEDICAL HISTORY INCLUDED STROKE, CORONARY ARTERY DISEASE, TESTICULAR CANCER, TYPE DIABETES, HEART ATTACK, QUADRUPLE BYPASS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041326 ↗
• MalfunctionJan 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE BROKE DURING INSERTION. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS LCS. THE PRODUCT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203064 ↗
• InjurySep 22, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, ABOUT THREE -FIFTH OF THE CAGE BACKED OUT INTO THE SPINAL CANAL. THE PATIENT ALSO EXPERIENCED PAIN DUE TO THIS EVENT. THIS ISSUE WAS CONFIRMED BY AN MEDICAL EXAMINATION. A REVISION SURGERY HAS BEEN PLANNED TO REMOVE THE CAGE AND TO IMPLANT AUTOLOGOUS BONE.

  Patient problems: Pain

  MAUDE report 9101894 ↗
• MalfunctionSep 11, 2018Break; Break

  PRE-OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS AT L4-5 AND S1 PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT INTRA-OP, THE CONNECTION PART OF THE CAGE BROKE UPON INSERTION. FRAGMENTS WERE REMOVED FROM THE PATIENT HOWEVER SOME MIGHT HAVE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863617 ↗
• MalfunctionJun 12, 2018Break; Break

  IT WAS REPORTED THAT INTRA-OP, IMPLANT BROKE IN HALF. THE TITANIUM SEPARATED FROM THE OTHER PART. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594707 ↗
• MalfunctionMar 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY. INTRA-OP, THE IMPLANT BROKE BY SHEER FORCE WHEN IT WAS BEING IMPLANTED. THE PEEK PORTION CAUGHT AND WAS STEERED FROM THE TI PORTION. THE IMPLANT WAS REPLACED BY THE SAME SIZE IMPLANT AND WAS IMPLANTED WITHOUT ISSUE. ALL THE FRAGMENTS OF THE BROKEN IMPLANT WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345084 ↗
• MalfunctionMar 14, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: BACK <(>&<)> LEG PAIN TYPE OF PROCEDURE OR TECHNIQUE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT INTRA-OP, THE PRODUCT BROKE. NO FRAGMENT OF THE PRODUCT REMAINING IN PATIENT . NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7338313 ↗
• InjuryJan 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT CAGE HAD MIGRATED INTO S1 DISC SPACE POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED TO EXPLANT THE MIGRATED CAGE.

  Patient problems: No Code Available

  MAUDE report 6272348 ↗