Catalyft PL Expandable Interbody System 6069096Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000246822), received between Nov 10, 2022 and Feb 25, 2026 — classified as 7 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING PATIENT FOLLOW-UP, A LATERAL X-RAY SHOWS THAT THE CAGE HAS MIGRATED. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. PATIENT IS ASYMPTOMATIC AT THIS TIME AND WILL RETURN IN A MONTH FOR ANOTHER FOLLOW UP VISIT. ADDITIONAL INFORMATION RECEIVED STATING PATIENT HAD A RECENT SCAN AND REMAINS ASYMPTOMATIC. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438755 ↗
• InjuryFeb 2, 2026Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE. IT WAS REPORTED THAT THE CAGE MIGRATED AND IT WAS EXPLANTED. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. 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 24231273 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT THE L2-4 LEVEL. IT WAS REPORTED THAT THE CAGE COLLAPSED AT L3-L4 (OUT OF L3-L5). THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON 19 JUNE 2025, UPDATE RECEIVED: NO REVISION SURGERY IS PLANNED/ PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532132 ↗
• MalfunctionJul 7, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO HAD TRANSFORAMINAL LUMBAR INTERBODY FUSION (L3/4/5) DUE TO SPINAL CANAL STENOSIS. IT WAS REPORTED THAT SPACERS HAD 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 22409819 ↗
• MalfunctionJul 7, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO HAD TRANSFORAMINAL LUMBAR INTERBODY FUSION (L3/4/5) DUE TO SPINAL CANAL STENOSIS. IT WAS REPORTED THAT SPACERS HAD POSTOPERATIVE JACK DOWN. THERE WASNO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409808 ↗
• MalfunctionJun 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 5/S1 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE CAGE JACKED 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 22326525 ↗
• InjuryApr 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST THE INITIAL ON (B)(6) 2023 T10-ILIAC FUSION PROCEDURE DUE TO ASD. IT WAS REPORTED THAT A ROD FRACTURE OCCURRED DUE TO THE CAGE JACKING DOWN ON 5/S. THIS RESULTED IN A REOPERATION FOR THE PATIENT WHERE CAGE WAS REMOVED AND REINSTALLED, AND THE ROD WAS 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 21898058 ↗
• InjuryMar 27, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CY CAGE WAS BACKED OUT INTO THE SPINAL CANAL POST-OPERATIVELY AND AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE BACKED-OUT CAGE WITH NP CAGE. THERE WERE NO NEUROLOGICAL SYMPTOMS. THE JACKED-UP STATE WAS MAINTAINED, BUT THE PHYSICIAN RECOGNIZED IT AS HAVING CONTRACTED AND BACKED OUT. THE PREVIOUS OPERATION IMAGES COULD NOT BE CHECKED, SO THE EXTENT OF CONTRACTION IS UNCLEAR. THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2025. IT WAS CONFIRMED POSTOPERATIVELY THAT THERE WERE NO ISSUES WITH THE CY MECHANISM. 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 21707921 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT LEVEL 1. IT WAS REPORTED THAT THERE WAS CAGE MALFUNCTION. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. THE PATIENT WAS ALIVE WITH NO INJURY. PATIENT HAD POST OPERATIVE BACK PAIN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS LOSS OF HEIGHT IN THE DEVICE. THERE WAS NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR AN ADDITIONAL SURGERY PERFORMED AS OF NOW. THERE WAS LOSS OF DISTRACTION AND DISLOCATION OF THE CAGE DORSALLY.

  Patient problems: Back pain; Pain

  MAUDE report 21580853 ↗
• MalfunctionJan 30, 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, ON (B)(6) 2024 THE CAGE HAD DISTRACTION LOSS FROM 15.1 TO 14MM, INCREASING CAGE SINTERING LUMBAR SPINE 2.3 LORDOSIS IDEM. DISTRACTION FAILURE OF THE INTERVERTEBRAL CAGE, HEIGHT LOSS WITHIN 2 MONTHS AFTER SURGERY (DORSOVENTRAL SPONDYLODESIS LV3-4). AS A RESULT, SCREW LOOSENING OF THE SCREW-ROD SYSTEM IN DORSAL SPONDYLODESIS LV3/4 AND LACK OF BONY FUSION IN THE TREATED SEGMENT. THE SCREW IMPLANTATION WAS INCONSPICUOUS. THE OPERATION TOOK PLACE ON (B)(6) 2024. THE X-RAY CONTROL ON (B)(6) 2024 SHOWED LOSS OF DISTRACTION OF THE CAGE AND SINTERING IN THE VERTEBRAL BODIES LUMBAR SPINE 2 AND 3 BOTH IN ANTERO-POSTERIOR AND SAGITTAL SEQUENCE. NO REVISION IS IN PLAN TO EXPLANT THE CAGE. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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

  MAUDE report 21280544 ↗
• InjuryJan 13, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT PERCUTAN EOUS STABILIZATION WITH TLIF CAGE SPINAL PROCEDURE FOR SPONDYLOLISTHESIS L4/5, DISCUSPROLAPS AT L4/5 RIGHT. LEVELS IMPLANTED 1. IT WAS REPORTED THAT THE CAGE COLLAPSED AFTER IMPLANTATION AND SCREW WAS BROKEN. THERE WAS A PIECE OF SCREW THREAD LEFT INSIDE THE PATIENT AND PATIENT HAD PAIN DUE TO BROKEN SCREWS. THERE IS A PLAN OF REVISION SURGERY AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 21137603 ↗
• MalfunctionDec 6, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR AN INDICATION OF ANTELISTHESIS L4/5 WITH SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE CAGE WAS COLLAPSED AFTER SEVERAL MONTHS OF IMPLANTATION. 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 20862817 ↗
• MalfunctionAug 19, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH VERTEBRAL SPACER. IT WAS REPORTED THAT 3 WEEKS POST OP, PATIENT SLIPPED IN THE BATHROOM AND HAS SINCE COMPLAINED OF BACK PAIN AND PAIN ON TWISTING. A FOLLOW UP XRAY SHOWED THAT THE CAGE HAS COLLAPSED. NO EXTENDED HOSPITAL STAY (EVENT OCCURRED POST SURGERY 3 WEEKS). NO DIRECT TRAUMA TO PATIENT INVOLVED IN EVENT. NO REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 20000291 ↗
• MalfunctionFeb 27, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY/ HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT I MPLANTED WITH A CAGE IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE CAGE COLLAPSED POST OPERATIVELY. LEVELS INVOLVED IS L3/L4/L5/S1. THE DATE OF IMPLANT WAS (B)(6) 2023. THE DATE OF LAST FOLLOW UP WAS (B)(6) 2023. IT IS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786710 ↗
• MalfunctionFeb 26, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY (RB) VIA HEALTHCARE PROFESSIONAL (HCP) VIA MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN UNKNOWN SPINAL THERAPY. LEVELS INVOLVED IS L5/S1 IT WAS REPORTED THAT THE CAGE COLLAPSED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776334 ↗
• MalfunctionFeb 9, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MULTIPLE SOURCES (COMPETENT AUTHORITY, HEALTHCARE PROFESSIONAL) VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. LEVEL AT WHICH IT WAS IMPLANTED: L5/S1 IT WAS REPORTED THAT THE RIGHT CAGE COLLAPSED. IT WAS ONLY PARTIALLY DEPICTED IN PET. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674960 ↗
• InjuryFeb 9, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY/ HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGES IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE CAGES COLLAPSED. LEVELS INVOLVED ARE L5/S1 AND L3/4. THE DATE OF IMPLANT WAS (B)(6) 2022. THE PATIENT EXPERIENCED PSEUDOARTHROSIS ON (B)(6) 2022. THE DATE OF REVISION SURGERY WAS (B)(6) 2022. THE DATE OF LAST FOLLOW UP WAS 27-JUN-23. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

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

  MAUDE report 18674134 ↗
• MalfunctionDec 12, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-5 TLIF FOR LUMBAR STENOSIS. IT WAS REPORTED THAT THE CAGE WAS SHRINKING 1 MONTH AFTER THE SURGERY 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 18308872 ↗
• InjuryDec 1, 2023Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CAGE HAS BEEN EXPLANTED.

  Patient problems: Pain; Unspecified Nervous System Problem

  MAUDE report 18244506 ↗
• MalfunctionSep 13, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L3/4 TLIF. IT WAS REPORTED THAT CAGES CONTRACTED IN TWO OF THE TWO INTERVERTEBRAL FUSIONS. 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 17735121 ↗
• MalfunctionAug 8, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE HAVE MIGRATED ANTERIORLY. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT AT THIS TIME, NO REVISION SURGERY HAS BEEN SCHEDULED/PLANNED FOR THE REMOVAL OF THE IMPLANT. THE PRE-OP DIAGNOSIS WAS DEGENERATIVE DISC DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478831 ↗
• MalfunctionMar 21, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST LEFT SIDED L5-S1 TLIF USING BILATERAL PEDICLE SCREWS IN A PATIENT WHO HAD 3 TIME RECURRENT DISC HERNIATION ( TWO PRIOR DISCECTOMIES) BACK AND LEFT LEG PAIN. IT WAS REPORTED THAT THE CATALYFT CAGE HAD COLLAPSED SINCE IMPLANTATION. THERE IS NO PLAN TO EXPLANT THE COLLAPSED CAGE. 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 16581059 ↗
• MalfunctionFeb 10, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH STENOSIS. IT WAS REPORTED THAT THE JACK-UP OF THE CAGE RETURNED. 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 16345658 ↗
• MalfunctionFeb 1, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A FUSION FOR STENOSIS. IT WAS REPORTED THAT THE JACK-UP OF THE CATALYFT HAD RETURNED. THERE WERE NO SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276328 ↗
• InjuryNov 10, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE SUBSIDED INTO THE END PLATE OF THE VERTEBRAL BODY OF L5. NO PATIENT COMPLICATIONS OR SYMPTOMS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REVISION SURGERY SCHEDULED FOR (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REVISION SURGERY WAS COMPLETED, BUT THE PRODUCT WAS LEFT IN AND THE SURGEON JUST DID MORE DECOMPRESSING INSTEAD OF REMOVING THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769230 ↗