ELEVATE™ Spinal System 8881023Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169430792), received between Apr 30, 2019 and Jun 18, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND SUB-EVENT NUMBER: 5. DESCRIPTION: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS LONG DESCRIPTION: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS ONSET DATE: 2022-07-25. OUTCOME STATUS: PENDING INTERVENTIONS: ACTION SUBTYPE: OTHER ACTION RESULT: YES- OBSERVATION ONLY ACTION SUBTYPE: OTHER RELEVANT ACTIONS ACTION RESULT: YES, SITE SERIOUSNESS ASSESSMENT: THERE IS NO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFE THREATENING AND MEDICAL INTERVENTION, BUT THE SEVERITY OF ADVERSE EVENT IS MODERATE. SITE RELATED ASSESSMENT: NOT RELATED TO INTERBODY FUSION, PLF GRAFTING MATERIAL, POSTERIOR FIXATION, SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE OR SURGICAL PROCEDURE. DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE IMAGES-1 ACTION RESULT: ABNORMAL ACTION DATE: (B)(6) 2022 ACTION INFO: DIAGNOSTIC TESTS PERFORMED: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE IMAGES-2 ACTION RESULT: ABNORMAL ACTION DATE: (B)(6) 2022 ACTION INFO: DIAGNOSTIC TESTS PERFORMED: UNCHANGED SINCE IMAGES ON (B)(6) 2022 RAN

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22260353 ↗
• InjuryNov 23, 2021Migration; Migration

  UPDATED INFORMATION RECEIVED: SITE SERIOUSNESS ASSESSMENT: DISABILITY - YES SITE RELATED ASSESSMENT: THERE IS CAUSAL RELATIONSHIP TO INTERBODY FUSION DEVICE, SURGICAL PROCEDURE AND RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. ADVERSE EVENT INFO: IF ONSET IS DATE OF INITIAL TREATMENT PROCEDURE, SPECIFY TIME FRAME: DURING PROCEDURE IRB REPORTABLE: NO OUTCOME STATUS: PERMANENT DISABILITY OR CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 12859430 ↗
• MalfunctionJun 25, 2020Break; Break

  PRE-OP DIAGNOSIS: NEEDED A "5/1" TLIF PROCEDURE INVOLVED: POSTERIOR LUMBAR FUSION (PLF) LEVELS IMPLANTED: L3-S1 IT WAS REPORTED THAT INTRA-OP, THE PEEK PORTION OF THE SPACER WAS BROKEN WHILE IMPLANTATION. SURGEON TRIED TO PUT-IN LARGER SIZE CAGE FOR THE SPACE. ONCE THE DEVICE BROKE DOCTOR DISTRACTED THE SPACE IN ORDER TO INSERT THE NEW CAGE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10193867 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-5 DUE TO SPONDYLOLISTHESIS. INTRA-OP, THE PEEK PORTION OF THE CAGE BROKE APART FROM TITANIUM WHILE INSERTING IN THE PATIENT BODY. THE BROKEN IMPLANT HAS BEEN REMOVED. NO FRAGMENTS OF THE BROKEN DEVICE REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563591 ↗