Catalyft PL Expandable Interbody System 6069093Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000246815), received between Jan 3, 2025 and Jul 6, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 16, 2025Open, Classified

   Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

   Z-0580-2026 · Root cause: Labeling design · Recall details · FDA record ↗

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 6, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CAGES WOULDN'T EXPAND PROPERLY AND ONLY ONE DEFECTIVE CAGE WAS IMPLANTED AND IT WAS EXPLANTED AND REPLACED. 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 25713399 ↗
• InjuryJul 3, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE IN WHICH TWO CAGES WERE IMPLANTED. DURING THE INITIAL SURGERY, BOTH CAGES WERE PLACED AND EXPANDED AS DESIGNED. ALMOST A YEAR LATER, ONE OF THE CAGES COLLAPSED AND MIGRATED TOWARD THE SPINAL CORD. IMAGING WAS CONDUCTED, WITH PICTURES OF THE AFFECTED AREA BEFORE AND AFTER THE EVENT UPLOADED. A PLANNED INTERVENTION WAS SCHEDULED FOR CAGE REMOVAL AND EXTENSION OF THE SPINAL FUSION. THERE WERE UNKNOWN PATIENT SYMPTOMS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE ADDITIONAL SURGERY PERFORMED AS PER PLAN AND THE CAGE HAS BEEN REMOVED ON (B)(6) 2025. THE PATIENT WEIGHT IS 121 KG OR ABOUT 266LB. SHE ALSO LOST 30 LBS IN THE LAST MONTH. BMI IS 45. THE PATIENT ORIGINALLY HAD A L3-L5 TLIF DONE, AND NOW EXTENDING DOWN TO S1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392978 ↗
• MalfunctionJun 30, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) THERAPY AT L3/4 FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT POSTOPERATIVE JACK DOWN WAS NOTICED FOR SPACER. 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 22368215 ↗
• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORA MINAL LUMBAR INTERBODY FUSION) THERAPY FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT POSTOPERATIVE JACK DOWN WAS NOTICED FOR SPACER. 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 22335295 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 TRANSFORAM INAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE CAGE HAS COLLAPSED. 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 22282093 ↗
• MalfunctionMar 13, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LW 4/5. IT WAS REPORTED THAT THE HEIGHT OF THE CAGE HASCHANGED POST IMPLANT. DATE OF SURGERY WAS (B)(6) 2024, DURING THE FIRST FOLLOW UP ON (B)(6) 2024, THERE WAS DISTRACTION LOSS FROM 11.6MM TO 10 MM. DURING THE SECOND FOLLOW UP ON (B)(6) 2024, DISTRACTION LOSS WAS ALMOST 9.8MM. PATIENT HAD POST OPERATIVE BACK PAIN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Back pain

  MAUDE report 21591889 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DISTRACTION LOSS FROM 12.9 TO 12.4MM AND A LORDOSIS LOSS FROM 11 TO 7.5° AFTER 2 MONTHS AND DISTRACTION LOSS 12.3MM AND A LORDOSIS LOSS TO 7° AFTER 7 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21290934 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF 4/5 SPINAL THERAPY. IT WAS REPORTED THAT THERE IS DISTRACTION LOSS 14.5 TO 13.8MM, LORDOSIS LOSS FROM 24.8 TO 17.2°. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO REVISION SURGERY OF THE IMPLANTS IS PLANNED SO FAR.

  Patient problems: Back pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280875 ↗
• MalfunctionJan 31, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A T LIF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE CAGE BROKE IN 2. THERE WAS DISTRACTION LOSS FROM 14 TO 12.7, SCREW LOOSENING OF LUMBAR SPINE, INCREASE IN SINTERING OF LUMBAR SPINE. ON (B)(6) 2024 DISTRACTION LOSS TO 10.9MM, LORDOSIS LOSS FROM 31 TO 29°. THE UNDERLYING PROBLEM IS LOSS OF DISTRACTION OF THE CAGE IN THE POSTOPERATIVE COURSE. NO REVISION IS CURRENTLY PLANNED ON THIS PATIENT. REVISION WILL BE CONSIDERED IN THE EVENT OF CLINICAL DETERIORATION. SCREW LOOSENING IS A SECONDARY CONSEQUENCE OF LOSS OF DISTRACTION AND SUBSEQUENT SINTERING OF THE INTERVERTEBRAL SPACE. THERE IS NO MALFUNCTION OF THE SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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

  MAUDE report 21280617 ↗
• MalfunctionJan 30, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A T LIF PROCEDURE. IT WAS REPORTED THAT DURING A FOLLOW-UP CHECK, A COLLAPSED CAGE WAS FOUND IN A PATIENT WITH A MEDICAL HISTORY OF SPINAL CANAL STENOSIS AT L4/5 AND DEGENERATIVE ANTEROLISTHESIS. NO PLAN TO EXPLANT THE CAGE. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AT THE TIME OF REPORTING. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272310 ↗
• MalfunctionJan 30, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE IN TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT THE E CT SCAN SHOWS A PSEUDOARTHROSIS L5/S1, CAGE SINTERING LWK 5, SWK 1, SCREW LOOSENING S1 BDS, DISTRACTION LOSS 15.2 TO 11.4MM, LORDOSIS LOSS 32 TO 30.8°. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO SCREW WAS LOOSENED, BUT THE CAGE SINTERED. THERE WAS NO ADDITIONAL/REVISION SURGERY PERFORMED OR PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Pain

  MAUDE report 21270801 ↗
• MalfunctionJan 3, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT CATALYFT CAGE COLLAPSED AFTER WEEKS IMPLANTATION. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IMPLANT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067037 ↗