ELEVATE™ Spinal System 7770728Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169430655), received between May 30, 2017 and Mar 30, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ENDOLIF (ENDO F USION). IT WAS REPORTED THAT THE CAGE FRACTURED INTO FRAGMENTS WHILE BEING INSERTED INTO THE PATIENT. 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 24725950 ↗
• MalfunctionNov 18, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT AFTER THE SURGEON INSERTED THE TRAIL AND DETERMINED THE SIZE OF IMPLANT, THE SCRUB NURSE FOUND THE IMPLANT CANNOT EXPAND TO MAXIMUM SO IT WAS REPLACED WITH THE NEW ONE. EVENTUALLY  THE SURGERY WAS FINISHED. EVENT OCCURRED WHEN THE SCRUB NURSE WAS PREPARING AT SETUP TABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703981 ↗
• MalfunctionJan 15, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT FOR THE FIRST CAGE, AFTER CONNECTING THE TOOLS TO THE IMPLANT, THE PHYSICIAN NOTICED FRAGMENTS APPEARING WHILE ATTEMPTING TO INSERT THE IMPLANT. UPON REMOVAL, IT WAS DISCOVERED THAT THE IMPLANT HAD BEEN DAMAGED. AFTER A PREVIOUS UNSUCCESSFUL ATTEMPT, THE PHYSICIAN OPTED FOR ANOTHER IMPLANT. FOLLOWING THE SAME PROCEDURE AS BEFORE, WHEN ATTEMPTING TO INSERT IT, THE ENTIRE IMPLANT SHATTERED. 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 18515253 ↗
• MalfunctionNov 7, 2022Break; Break

  ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. THERAPY INVOLVED IN THE EVENT WAS L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND PRE-OP DIAGNOSIS WAS DEGENERATIVE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742116 ↗
• MalfunctionJan 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE ELEVATE SPACER WAS PLACED PROPERLY ON THE INSERTER AND TAPPED INTO THE PATIENT. THE SURGEON NOTICED THAT WHEN HE PLACED IT INTO THE PATIENT IT BROKE AND IT WAS SEEN ON THE X-RAY. ALL PARTS WERE REMOVED INTACT. THERE WAS NO DELAY IN THE PROCEDURE, IT WAS QUICKLY REPLACED WITH ANOTHER SPACER. THE BROKEN CAGE WAS REMOVED FROM THE PATIENT. THERE WERE NO SYMPTOMS TO PATIENT REPORTED AS A RESULT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.  NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13332459 ↗
• MalfunctionJul 13, 2020Material Deformation; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: ISTHMIC SPONDYLOLISTHESIS PROCEDURE PERFORMED: 5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) POST-OP, DURING A REGULAR FOLLOW-UP SEVERAL MONTHS AFTER THE OPERATION THE SURGEON NOTICED THAT THE CAGE WHICH WAS LENGTHENED DURING THE OPERATION HAS RETURNED TO ITS ORIGINAL CLOSED STATE . THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262528 ↗
• MalfunctionNov 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION. INTRA-OP, THE PEEK PART OF THE CAGE SEPARATED FROM THE TITANIUM PART. THE PEEK PART WAS REMOVED WHILE THE TITANIUM PART OF THE CAGE WAS LEFT IMPLANTED WITHIN THE PATIENT AS A STATIC CAGE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9386578 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) DUE TO SPONDYLOLISTHESIS. INTRA-OP, CAGE BROKE WHILE INSERTING INTO THE DISC SPACE AND IT WAS REMOVED. NO BROKEN FRAGMENTS WERE REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563574 ↗
• MalfunctionApr 9, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE SPONDYLOLISTHESIS PROCEDURE: TLIF ( TRANSFORAMINAL LUMBAR INTERBODY FUSION) LEVELS IMPLANTED: L3/4 IT WAS REPORTED THAT INTRA-OP, PART OF PEEK BROKE WHILE HAMMERING THE SPACER IN. NO FRAGMENTS OF THE PRODUCT REMAIN IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494798 ↗
• MalfunctionJul 28, 2018Break; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRA-OPERATIVELY 2 CAGES WERE BROKE WHILE IMPACTED. THE PEEK PART WAS CRACKED OFF WHERE THE IMPLANT INSERTER CONNECTED. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF BROKEN CAGE WERE REMAINED IN PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7729644 ↗
• MalfunctionFeb 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FORAMINAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING SURGERY, THE CAGE BROKE. WHILE IMPACTING THE CAGE INTO THE VERTEBRAL BODY/ENDPLATE, IT CAUSED THE PEEK PORTION OF THE CAGE TO GET HUNG UP; THUS RIPPING OFF THE PEEK PORTION OF THE IMPLANT. THE CAGE FULLY COLLAPSED BEFORE BEING INSERTING IN. NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7258610 ↗
• MalfunctionFeb 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FORAMINAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING SURGERY, THE CAGE BROKE. WHILE IMPACTING THE CAGE INTO THE VERTEBRAL BODY/ENDPLATE, IT CAUSED THE PEEK PORTION OF THE CAGE TO GET HUNG UP; THUS RIPPING OFF THE PEEK PORTION OF THE IMPLANT. THE CAGE FULLY COLLAPSED BEFORE BEING INSERTING IN. NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7258608 ↗
• MalfunctionDec 5, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AT L2-L3 AND POSTERIOR SPONDYLOLISTHESIS AT L2. PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTER-BODY FUSION. DURING SURGERY, WHEN THE SURGEON WAS INSERTING A CAGE TO INTERVERTEBRAL DISC FROM ITS PEEK PART (CRANIAL SIDE), THE PEEK PART OF THE CAGE (ESPECIALLY ITS TIP PART) TOUCHED THE VERTEBRAL ENDPLATE AND BROKE. THE PEEK PART AND TITANIUM PART GOT SEPARATED. BEFORE INSERTION, THE SURGEON EXPANDED THE CAGE TO CONFIRM IF THE FUNCTIONALITY WOULD WORK AS INTENDED AND AFTER THE CONFIRMATION HE SHRUNK THE CAGE. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO BROKEN FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081970 ↗
• MalfunctionSep 14, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, AFTER PREPARATION OF DISC SPACE WHEN THE SPACER WAS BEING INSERTED INTO DISC SPACE,UPON IMPACTION THE PEEK PORTION OF THE SPACER FRACTURED AT THE BACK OF THE SPACER. TWO SMALL FRAGMENTS BROKE OFF. THE PRODUCT WAS EXPLANTED COMPLETELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864168 ↗
• MalfunctionAug 16, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, AT THE TIME OF THE IMPLANTING THE CAGE, THE PEEK PORTION OF THE CAGE COMPLETELY BROKE APART FROM THE TITANIUM PORTION. AS A RESULT THE SURGEON EXPLANTED BOTH PIECES OF THE CAGE. NO FRAGMENT OF THE CAGE REMAINED IN PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6796534 ↗
• MalfunctionMay 30, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE INTERBODY DEVICE BROKE INTO TWO PIECES UPON INSERTION. NO FRAGMENTS REMAIN IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6597221 ↗