ELEVATE™ Spinal System 8880823Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169430778), received between May 23, 2017 and Aug 22, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 LAMINECTOMY AND POSTEROLATERAL INTERBODY FUSION (BILATERAL). IT WAS REPORTED THAT WHEN ATTEMPTING TO IMPLANT THE CAGE, THE INSERTER WAS IMPACTED WITH A MALLET AND PART OF THE PEEK SECTION OF THE CAGE BROKE. 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 22870393 ↗
• MalfunctionMay 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERWENT MIS-TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT CAGE WAS BROKEN. REPLACED THE NEW ONE CAGE AND FINISHED THE SURGERY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051910 ↗
• MalfunctionJan 30, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH THE SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT DID NOT LOCK WHEN ATTACHED TO THE INSERTER, AND IT WAS NOT EXPANDABLE. THE IMPLANT DOES NOT REMAIN IN THE PATIENT AND THE IMPLANT WAS REMOVED DURING THE SURGERY. IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NOT NECESSARY, AND NO ADDITIONAL OR REVISION SURGERY WAS PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271807 ↗
• MalfunctionAug 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR DIAGNOSED L4-5 HIVD AND GRADE I SPONDYLOSIS. IT WAS REPORTED THAT THE CAGES WERE BROKEN. AFTER DISCECTOMY, THE SURGEON USED TRAIL TO DETERMINE THE SIZE OF IMPLANTS. THE SURGEON INSERTED IMPLANT INTO THE SPACE. WHEN THE HAMMER WAS USED TO HIT THE INSERTER, THE CAGE WAS BROKEN. THEN THE SURGEON REMOVED THE CAGE AND REPLACED WITH THE NEW ONE. HE REPEATED THE SAME PROCEDURE AND CAGE WAS BROKEN. HE REPLACED THE THIRD CAGE AND 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 19904321 ↗
• MalfunctionMay 20, 2024Crack; Crack

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT WAS CRACKED BEFORE IT WAS IMPLANTED. 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 19349667 ↗
• InjuryJul 31, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED AFTER AN UNKNOWN INITIAL SPINAL FUSION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT CAGE WAS BACKING OUT AND PATIENT WAS IN SIGNIFICANT PAIN, HENCE IT WAS REMOVED AND REPLACED WITH BONE GRAFT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17422627 ↗
• MalfunctionMay 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT ELEVATE SPACER BROKE DURING INSERTION WHILE STILL ON INSERTER. THE SPACER WAS STILL ATTACHED AND REMOVED BEFORE IMPLANTED IN 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 14406533 ↗
• MalfunctionApr 7, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE L2/3 STENOSIS WITH FACET DIASTASIS, L3/4 STENOSIS AND HERNIATED DISC AND GRADE 1 SPONDYLOLYSTHESIS. THERE WERE NO PIECES OF THE IMPLANT SAVED TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14037353 ↗
• MalfunctionMar 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF DEGENERATIVE DISC DISEASE IN NEED OF L4-S1 LUMBAR INTERBODY FUSION/ARTHRODESIS USED IN SPINAL THERAPY. IT WAS REPORTED THAT UPON INSERTING THE CAGE INTO THE DISC SPACE, THE SURGEON NOTICED THAT THE BACK OF THE PEEK PORTION OF THE CAGE DETACHED FROM THE TITANTIUM PORTION. HE PULLED THE CAGE OUT AND EXAMINED, ALL PIECES WERE ACCOUNTED FOR AND PASSED THE CAGE OFF THE FIELD AND A NEW CAGE WAS OPENED AND INSERTED. THERE WAS A DELAY OF ABOUT 2 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431948 ↗
• MalfunctionJul 8, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH SPONDYLOLISTHESIS,VP SHUNT FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS- INITIALS- (B)(6), GENDER- MALE, AGE (AT THE TIME OF EVENT)- (B)(6), WEIGHT- (B)(6) KG, DATE OF IMPLANT- (B)(6) 2020, DATE OF EXPLANT- (B)(6) 2020, DEVICE STATUS- EXPLANTED-COMPLETE. IT WAS REPORTED EVENT OCCURRED INTRA-OP, THE ELEVATE CAGE FRACTURED DURING IMPLANTATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. UPDATE RECEIVED ON 07 JUL 2020: PRE OP DIAGNOSIS WAS SPONDYLOLISTHESIS AND STENOSIS. PROCEDURE WAS AN L5-S1 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) NO FRAGMENTS LEFT BEHIND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10243729 ↗
• MalfunctionMar 23, 2020Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE IMPLANT BROKE; AND HENCE, WAS COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9868206 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO UNKNOWN REASON. INTRA-OP, DURING IMPLANTATION THE PEEK PORTION OF THE SPACER BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074408 ↗
• MalfunctionApr 3, 2019Break; Break

  PRE OPERATIVE DIAGNOSIS: L4/5 L5/S1 LISTHESIS AND STENOSIS PROCEDURE: MINIMALLY INVASIVE SPINE SURGERY (MIS) AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) IT WAS REPORTED THAT, INTRA-OP, POSTERIOR PART OF THE PEEK HINGE BROKE WHEN TRIED TO IMPLANT AS PER SURGICAL TECHNIQUE. IT WAS IMMEDIATELY REPLACED. NO FRAGMENTS OF THE BROKEN PRODUCTS 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 8477635 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, PEEK PORTION OF CAGE FRACTURED AWAY FROM TITANIUM PORTION OF CAGE AS IT WAS BEING INSERTED. THE CAGE WAS CHECKED THOROUGHLY TO ENSURE IT WAS FULLY COLLAPSED BEFORE INSERTING. NO FRAGMENTS WERE LEFT IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8244009 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L5-S1 LEVELS. POST-OPERATIVELY, THE SPACER BROKE.THE SPACER WAS SUCCESSFULLY EXPLANTED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7841178 ↗
• InjuryJul 11, 2018Problem with Sterilization

  IT WAS REPORTED THAT THE PATIENT UNDERWENT S1 DISC EXCISION, TRANSFORAMINAL LUMBAR INTERBODY FUSION AND POSTERIOR FUSION DUE TO LEFT L5 HEMILAMINECTOMY. POST-OP, AN INFECTION WAS INTRODUCED TO PATIENT'S LOWER SPINE BECAUSE PRODUCTS USED DURING THE SURGERY WAS NOT PROPERLY STERILIZED. AS A RESULT, PATIENT DEVELOPED A SEVERE INFECTION AND SEPSIS. PATIENT HAS ENDURED PAIN AND SUFFERING, HAD TO UNDERGO MULTIPLE EXTENDED HOSPITAL STAYS FOR INFECTION, INCURRED MEDICAL BILLS, AND MENTAL ANGUISH.

  Patient problems: Pain; Sepsis; Unspecified Infection

  MAUDE report 7676911 ↗
• MalfunctionMay 23, 2017Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE LUMBAR SPINE DISC DISEASE PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS: L4-5 IT WAS REPORTED THAT DURING SURGERY, DISTAL TIP OF CAGE GOT STUCK AGAINST PATIENT BONY SURFACE UPON ATTEMPTED INSERTION. THE EXPANDABLE PIECE BROKE OFF UPON FORCING THE DEVICE. WHETHER ANY FRAGMENT OF CAGE REMAINED INSIDE THE PATIENT OR NOT WAS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6583795 ↗