ELEVATE™ Spinal System 8657001Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169432178), received between Oct 4, 2017 and May 26, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Mechanical Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING EQUIPMENT INSPECTION, THE USER TESTED THE THREADED INNER TUBE OF THE ELEVATE SYSTEM BY THREADING IT INTO THE OUTER INSERTER SLEEVE AND NOTICED THAT IT WAS BECOMING INCREASINGLY DIFFICULT TO SCREW IN. THE USER TRIED THREE DIFFERENT THREADED INNER TUBES, BUT ALL SHOWED THE SAME DIFFICULTY. BASED ON THIS, THE USER CONCLUDED THAT THE OUTER INSERTER WAS BREAKING DOWN ON ITS INTERNAL THREADS. 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 25273794 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, INSERTER WOULD NOT INSERT INTO IMPLANT. IT WAS LATER FOUND THAT THE INSERTER HAD SEVERAL THREADS THAT HAD BEEN BROKEN OFF. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH REPORTED CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575115 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPLANTING AN ELEVATE INTERBODY, ONE OF THE PRONGS AT THE DISTAL END OF THE INSERTER WHICH WAS HOLDING THE IMPLANT IN THE PROPER ORIENTATION BROKE OFF OF THE INSERTER. ANOTHER INSERTER WAS USED TO COMPLETE THE INTERBODY INSERTION SUCCESSFULLY AND THE BROKEN PRONG WAS RECOVERED. NO DELAY TO PROCEDURE OR COMPLICATIONS TO 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 24569833 ↗
• MalfunctionJul 14, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492186 ↗
• MalfunctionJun 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR SPINAL SURGERY. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE HANDLE BROKE OFF THE INSERTER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830704 ↗
• MalfunctionApr 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A MDLIF PROCEDURE. IT WAS REPORTED THAT DURING SURGERY THE INTERBODY WAS LOADED ONTO THE INSERTER, AS THE PHYSICIAN WAS GOING TO PLACE THE INTERBODY INTO THE PATIENT, THE PEEK HINGE BROKE. THE PIECES WERE ACCOUNTED FOR NO BROKEN PIECE WERE IN THE PATIENT. THIS WAS CONFIRMED VIA X-RAY. AN ADDITIONAL INTERBODY WAS PLACED SUCCESSFULLY IN THE PATIENT. WHILE ADJUSTING THE SECOND INTERBODY, THE INSERTER WAS PLACED BACK INTO THE PATIENT AND LIGHTLY TAPPED, THE 2 SIDE METAL PIECES BROKE OFF, BUT WERE IMMEDIATELY SUCTIONED. THE METAL PIECES WERE CLEARLY SEEN IN SUCTION CONTAINER AND A DIFFERENT INSERTER WAS PROVIDED TO THE PHYSICIAN TO COMPLETE THE REST OF THE PROCEDURE. PRODUCT CAME IN CONTACT WITH THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14235390 ↗
• MalfunctionJan 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A PLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE INSERTER BROKE WHILE INSERTING CAGE. THE CAGE WAS REMOVED AND REPLACED. 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 13140360 ↗
• MalfunctionAug 5, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE ONE OF THE PRONGS AT THE TIP OF THE INSERTER THAT THE CAGE SITS IN IS BROKEN. DURING THE INSERTION OF THE INTERBODY, SURGEON EXPANDED THE INTERBODY. AFTER CONFIRMATION OF THE PLACEMENT OF THE CAGE, HE REATTACHED THE INSERTER, COLLAPSED THE CAGE, THEN ADVANCED THE CAGE MORE ANTERIORLY AND EXPANDED THE CAGE. SURGEON FELT THAT THE INSERTER WAS LOOSE ON THE IMPLANT AND OBSERVING THE TIP OF THE INSERTER, ONE OF THE PRONGS WERE MISSING. AP AND LATERAL XR WERE TAKEN AND EVALUATED BY RADIOLOGY. ALSO, BEFORE INSERTION OF THE INTERBODY, IT WAS IDENTIFIED THAT THE TIP OF THE INSERTER DRIVE SHAFT WAS BROKEN OFF. THIS INSTRUMENT WAS NOT USED DURING THE PROCEDURE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278882 ↗
• MalfunctionApr 1, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT ONE OF THE ALIGNMENT TABS THAT HOLD THE IMPLANT SECURE BROKE DURING INSERTION. NO PATIENT SYMPTOM REPORTED. DEVICE IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600910 ↗
• MalfunctionMar 1, 2021Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION RECEIVED FORM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING A PROCEDURE OF TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED ON 8TH FEB TO REMOVE/REPLACE A SCREW AND ADVANCE THE INTERBODY CAGES ANTERIOR. THE SCREW WAS REDIRECTED WITHOUT ISSUE. THE SURGEON TRIED TO RE-ATTACH THE ELEVATE INSERTER TO THE ELEVATE CAGE TO COLLAPSE THE DEVICE. BUT WAS UNABLE TO ATTACH. THEN, THE SURGEON USED THE ELEVATE INSERTER TO IMPACT THE CAGE TO ADVANCE ANTERIORLY. UPON IMPACTION, THE TIP OF THE INSERTER BROKE OFF. THE SURGEON SEARCHED FOR THE FRAGMENT WITH FORCEPS AND MICROSCOPE AS WELL AS UNDER FLUOROSCOPY BUT UNABLE TO RETRIEVE FRAGMENT. THE FRAGMENT WAS NOT IDENTIFIED UNDER FLUOROSCOPY, THEN HE USED A STANDARD TAMP AND WAS ABLE TO ADVANCE THE CAGE. AFTER THE INITIAL PROCEDURE, RADICULOPATHY WAS NOT RELIEVED WHICH CAUSED THE SURGEON TO RE-OPERATE. THE THERAPY INVOLVED DURING THIS EVENT WAS L4-S1 TLIF. THERE WAS A DELAY OF APPROXIMATELY 10 MINUTES OCCURRED AS A RESULT OF INSERTER BREAKAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11391509 ↗
• MalfunctionOct 14, 2020Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS PROCEDURE. IT WAS REPORTED THAT THE SURGEON NOTICED SHAVINGS FROM THREADED SHAFT WHEN ATTACHING IMPLANT. DURING IMPLANTATION BOTH TABS BROKE OFF ON INSERTER. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10675899 ↗
• MalfunctionAug 20, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF L3/4 ,L4/S1 PLIF. IT WAS REPORTED THAT INTRA-OP, INSERTER ELEVATE AND ITS INNER LOCKING TUBE BREAK. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PRODUCTS WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10429927 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED THAT INTRA-OP, TIP OF THE INSERTER BROKE DURING INSERTION OF THE IMPLANT. THE BROKEN PIECE WAS IMMEDIATELY VISUALIZED AND RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9921335 ↗
• MalfunctionMar 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION DUE TO DEGENERATIVE DISC DISEASE. INTRA-OP, THE HANDLE OF THE INSERTER BROKE WHILE INSERTING THE CAGE INTO THE DISC SPACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9863468 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY AT L4-S DUE TO LUMBAR DEGENERATIVE DISC DISEASE. INTRA-OP, THE INSERTER WAS ATTACHED TO AN ELEVATE CAGE AND AFTER THE CAGE WAS PLACED, A LATERAL X-RAY WAS TAKEN TO CONFIRM CAGE PLACEMENT. AT THAT TIME IT WAS FOUND THAT A FRAGMENT (BROKEN TIP) OF THE CAGE INSERTER WAS LEFT INSIDE THE PATIENT. THE SURGEON SPENT ABOUT 30 MINUTES OF ADDITIONAL SURGICAL TIME TO RETRIEVE THE FRAGMENT (BROKEN TIP). LATER, SURGEON WAS ABLE TO REMOVE IT SUCCESSFULLY. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9518387 ↗
• MalfunctionNov 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE TAB AT THE END OF THE INSERTER SNAPPED OFF WHEN IMPACTING IMPLANT. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9339551 ↗
• InjuryJun 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 DUE TO L3-L5 STENOSIS. INTRA-OP, THE METAL WING ON THE TIP OF THE INSERTER BROKE-OFF AND WAS LEFT ATTACHED TO THE IMPLANT. THE BROKEN FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT; HOWEVER, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8702392 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. DURING SURGERY, THE INSERTER HANDLE WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431147 ↗
• InjuryOct 4, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVEL L4-5 DUE TO DEGENERATIVE DISC DISEASE, DISC HERNIATION WITH RADICULOPATHY, AND SPONDYLOSIS LOW BACK PAIN SCIATICA RIGHT SIDE. DURING THE SURGERY, INNER SLEEVE APPEARED TO HAVE CROSS THREADED THE IMPLANT AND OUTER SHAFT PRONG BROKE OFF. PRONG WAS RETRIEVED AND THREADS WOULD NOT REATTACH. IMPLANT WAS HALF-WAY IN AND IT WAS TAMPED IN REMAINDER OF DISTANCE WHEN THE DURAL TEAR OCCURRED. THE OVERALL PROCEDURE TIME WAS EXTENDED BY 1 HOUR.

  Patient problems: Spinal Column Injury

  MAUDE report 6913977 ↗