Catalyft PL Expandable Interbody System 6069073Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000246785), received between Mar 18, 2024 and Feb 9, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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.

• MalfunctionFeb 9, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH SPACER IN L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT AFTER THE TLIF PROCEDURE, THE CAGE HAS COLLAPSED. SINCETHE PATIENT IS NOT EXHIBITING ANY SYMPTOMS, IT HAS BEEN DECIDED TO MONITOR THE SITUATION AS IT IS. THE PHYSICIAN MENTIONED THAT MORE TORQUE SHOULD HAVE BEEN APPLIED. THE SURGERY WAS PERFORMED IN (B)(6) 2025, BUT IMAGING EVERY 3 MONTHS POSTOPERATIVELY SHOWS THAT THE CAGE IS GRADUALLY COLLAPSING. 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 24289356 ↗
• MalfunctionJul 16, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT POSTERIO RLY FIXATED L5/S FOR L5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE JACKED DOWN. THERE WAS NO IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR ADDITIONAL/REVISION SURGERY PERFORMED. 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 22517874 ↗
• MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING WHO HAD TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE DUE TO SPINAL CANAL STENOSIS. IT WAS REPORTED THAT SPACER HAS POSTOPERATIVE JACK DOWN. 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 22394832 ↗
• MalfunctionJun 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT POSTERIO RLY FIXATED L5/S FOR L5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE JACKED DOWN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR ADDITIONAL/REVISION SURGERY PERFORMED. THER E WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325662 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE CATALYFT CAGE COLLAPSE WAS FOUND AT 24 MONTH POST-OP. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L3-L5. 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 22275944 ↗
• MalfunctionMar 17, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A TLIF. IT WAS REPORTED THAT THE DOCTOR DID A TLIF ON THIS PATIENT AND USED THE CATALYFT PL40 IMPLANT. FINAL IMAGES SHOWED THAT THE CAGE EXPANDED. HE SAW THE PATIENT BACK IN CLINIC 6 WEEKS POST OPERATIVE AND THE CAGE HAD COLLAPSED, SOMEWHERE BETWEEN 2 AND 6 WEEKS AFTER BEING IMPLANTED. 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 21619876 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE CAGE HAS LOST DISTRACTION HEIGHT FROM 12 TO 11MM, LORDOSIS LOSS 14.6 TO 12.1° IMPLANTED AT THE LEVEL L4/L5. PATIENT HAD POST OPERATIVE BACK PAIN. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Back pain

  MAUDE report 21581199 ↗
• MalfunctionFeb 10, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS-PLIF, THE I MPLANT WAS PERFORMED AT L5/S FOR LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT A CAGE WAS INSERTED FROM BOTH SIDES ON THE JACK-DOWN WAS CONFIRMED DURING AN X-RAY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO PLAN FOR REVISION SURGERY, HOSPITALIZATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO HOSPITALIZATION OR REVISION SURGERY PERFORMED. TWO EACH OF THIS PRODUCT WERE USED, SO UNKNOWN WHICH WAS MALFUNCTIONED. THE CAGES REMAIN IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341862 ↗
• MalfunctionFeb 3, 2025Break; Mechanical Problem; Break; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE PATIENT HAD POST OPERATIVE BACK PAIN. LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT THERE WAS CAGE SINTERING WITH THE IMPLANTED CAGE RESULTING IN DISTRACTION LOSS FROM 10.1 TO 8.4MM. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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

  MAUDE report 21291500 ↗
• MalfunctionOct 31, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/3 POSTERIOR LUMBAR INTERBODY FUSION FOR LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT THE JACKED-UP CAGE WAS CLOSED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO REVISION SURGERY PERFORMED/PLANNED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576224 ↗
• InjuryJul 9, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST L4/5 PERC SCREWS/MIDLINE INCISION FOR INTERBODY IN A PATIENT DIAGNOSED WITH BACK AND LEG PAIN . IT WAS REPORTED THAT PATIENT PRESENTED FOR FOLLOW-UP COMPLAINING OF LEG PAIN. RESCANNED AND CAGE SHOWN TO HAVE BACKED OUT INTO CANAL. ON CT THE SCREWS HAVE ALSO OBSERVED TO HAVE LUCENCY AROUND THEM. SCREWS LOOSENED DUE TO THE LACK OF ANTERIOR COLUMN SUPPORT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19699660 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY ANT L4-5 LEVELS. IT WAS REPORTED THAT THIGH PAIN RIGHT GREATER THAN LEFT PAIN IS IN THE L3-L4 DISTRIBUTION. PRIMARY DIAGNOSIS: INSTABILITY ADDITIONAL INFORMATION WAS RECEIVED THAT PER SPONSOR POSSIBLE RELATED TO PROCEDURE, GRAFTING MATERIAL, INTERVERTEBRAL BODY FUSION DEVICE AND POSTERIOR SUPPLEMENTAL FIXATION. MEDROL DOSE PACK (PRESCRIBED) UNKNOWN IF USED. SYMPTOMS: PAIN (SINCE DISCHARGE), WITH MOTOR AND SENSORY SYMPTOMS. PATIENT WAS HOSPITALIZED AND REOPERATED ON (B)(6) 2024 BY OUTSIDE SURGEON, NO MDT REP INVOLVED. THE STUDY SITE AND MEDTRONIC ASSESSED THIS ADDITIONAL SURGICAL PROCEDURE AS: POSSIBLE RELATED TO THE STUDY PROCEDURE, TLIF GRAFTING MATERIAL, INTERVERTEBRAL BODY FUSION DEVICE, POSTERIOR SUPPLEMENTAL FIXATION SYSTEM NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Neuropathy; Pain; Unspecified Nervous System Problem

  MAUDE report 18919995 ↗