Catalyft PL Expandable Interbody System 6068096Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000246730), received between Aug 22, 2022 and Feb 24, 2026 — classified as 1 injury, 19 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SPACER DID NOT FIT CORRECTLY. THE PRODUCT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRPCEDURE WAS TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION. WHEN THE IMPLANT WAS EXPANDED TO ITS MAX, THE DEVICE WAS NOT TIGHT ENOUGH IN THE DISC SPACE. THE SURGEON DIDN'T FEEL COMFORTABLE LEAVING. THEY REPLACED IT WITH A BIGGER CAGE. PROCEDURE WAS A SUCCESS ONCE WE RESIZED THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426166 ↗
• MalfunctionJun 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING (TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) SPINAL THERAPY. IT WAS REPORTED THAT CAGE COLLAPSED 4MONTHS POST OP.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT IN HIS EARLY USE OF THE DEVICE, SURGEON MOST OFTEN APPLIED FULL TORQUE USING HANDLE. CURRENTLY HE DOES SO ABOUT 50% OF THE TIME AND HAS NOT ROUTINELY INDICATED THE USE OF TORQUE IN HIS OPERATIVE REPORTS. THERE ARE INSTANCE WHERE HE DOES NOT FEEL COMFORTABLE USING TORQUE DUE TO THE PERCEIVED QUALITY OF THE BONE INTRAOPERATIVELY AND DOES NOT FULLY TORQUE. HE MOST OFTEN USES A 10MM SCRAPER WHEN SIZING, AND WILL THEN OFTEN IMPLANT A 9MM DEVICE, ALLOWING FOR A LITTLE EXTRA SPACE. SOMETIMES USES TRIALS FOR SIZING. USES IMAGE GUIDANCE FOR PLACEMENT AND MONITORS EXPANSION OF THE IMPLANT UNDER FLUORO. USES PERCUTANEOUS SCREW (LIKE VOYAGER), BUT GENERALLY DOES NOT COMPRESS POSTERIORLY. MOST ARE UNILATERAL APPROACH (MAYBE 80% OF THE TIME WITH TILF APPROACH) NOTED THAT POSTERIOR COMPRESSION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22295024 ↗
• MalfunctionJun 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE IN L3/4 MIS TLIF (MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT THE L3/4 CAGE 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 22294671 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD MINIMALLY INVA SIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT THE L4/5 LEVEL. IT WAS REPORTED THAT THE CAGE COLLAPSED AT L4/5. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283575 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A MINIMALLY INV ASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT THE L4-L5 LEVEL. 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 22281781 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE IS NO REVISION SURGERY SCHEDULED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22281198 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE IN L3/4/5 MIS TLIF (MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT THE L3/4 CAGE 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 22275270 ↗
• MalfunctionJun 18, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  THERE WAS NO PLAN/SCHEDULE FOR REVISION SURGERY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22268601 ↗
• MalfunctionJun 17, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-4 TLIF MIS. IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2024 AND THE CATALYFT CAGE WAS FOUND COLLAPSED POSSIBLY AT L2/3 DURING 6 MONTH FOLLOW UP VISIT. THERE WAS GRADE 1 CAGE SUBSIDENCE NOTED AS WELL. 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 22221190 ↗
• MalfunctionJun 17, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD MINIMALLY INVA SIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT THE L4/5 LEVEL. IT WAS REPORTED THAT THE CAGE COLLAPSED AT L4/5 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 22220732 ↗
• MalfunctionJun 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 4/5 MIS TLIF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THERE IS A POSSIBLE CAGE COLLAPSE AT 3 MONTH FOLLOW UP. 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 22192161 ↗
• MalfunctionMay 5, 2025Mechanical Problem; Mechanical Problem

  THE PROCEDURE INVOLVED DURING THE EVENT WAS MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT THE L4/5 LEVEL.

  Patient problems: Pain

  MAUDE report 21957738 ↗
• MalfunctionFeb 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE DISC WITH STENOSIS. IT WAS REPORTED THAT, EXPANDING DRIVER WOULD NOT ENGAGE IMPLANT ON THE INSERT AND EXPAND THE IMPLANT. THE PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WAS NO MALFUNCTION ASSOCIATED WITH REPORTED EXPANDING DRIVER. THE CAGE WOULD NOT ENGAGE THE EXPANDING DRIVER WHILE IT WAS SEATED ON THE INSERTED; THEREFORE, IT WOULD NOT EXPAND. THE REPORTED CAGE CAME IN CONTACT WITH PATIENT BODY, PHYSICIAN THEN TRIED TO EXPAND. IT WOULD NOT ENGAGE AND EXPAND SO THE CAGE WAS REMOVED AND REPLACED IT. THERE WAS A DELAY OF 3-5 MINUTES REPORTED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444268 ↗
• MalfunctionJan 13, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS L4-L5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT, SURGEON REPEATEDLY HAD ISSUE WITH THE IMPLANT MIGRATING POSTERIORLY UPON EXPANSION. HE IS CONSCIENCE OF PUTTING DOWNWARD PRESSURE ON THE INSERTER WHILE EXPANSION BUT STILL HAS THE ISSUE.  PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT THE LEVELS L4-L5. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135317 ↗
• MalfunctionApr 22, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN L 4/5 MISPLIF SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT PATIENT HAD RECURRENT LEG SYMPTOMS AND BACK PAIN. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CAGE HAS COLLAPSED ITS EXPANSION AND PATIENT HAD NO FUSION. THERE IS NO REVISION SURGERY IS SCHEDULED AT THE MOMENT.

  Patient problems: Pain; Unspecified Nervous System Problem

  MAUDE report 19152117 ↗
• InjuryOct 11, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN UNKNOWN SPINAL SURGERY. IT WAS REPORTED THAT THE CAGE HAS BEEN MIGRATED AND NEEDED TO TAKE OUT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578710 ↗
• MalfunctionSep 29, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MIS TLIF THERAPY. IT WAS REPORTED THAT THE CAGE WAS MIGRATED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507174 ↗
• MalfunctionSep 22, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SPACERS USED IN MIS TLIF THERAPY. IT WAS REPORTED THAT THE CAGE HAD MIGRATED. ACCORDING TO POST-OP IMAGING, THE PATIENT HAD ANTEROLISTHESIS WITH THE CAGE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 15469138 ↗
• MalfunctionSep 19, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A 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 FIRST CAGE MIGRATED AND THERE WAS NO ISSUE WITH THE SECOND CAGE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT 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 15444767 ↗
• MalfunctionAug 22, 2022Mechanics Altered; Migration; Mechanics Altered; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPO RTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT, A CAGE WAS INSERTED ON (B)(6). PL LONG WAS USED AND PLACED ONE PIECE ON ONE SIDE. BECAUSE IT MAKES A SQUEAKY-LIKE NOISE FOR ABOUT 3 TO 4 TURNS, THEN THE OPENING IS STOPPED. IT WAS CONFIRMED FROM THE IMAGE THAT THE CAGE WAS FIRMLY OPENED AND ADHERED TO THE END OF THE VERTEBRAL BODY. AFTER THAT, ANOTHER COMPANY'S SCREW WAS INSERTED AND COMPRESSION WAS APPLIED TO CLOSE THE INCISION. AT POST ONE MONTH AFTER SURGERY, THERE WAS NO PROBLEM, BUT AFTER THAT, IT WAS CONFIRMED WITH THE IMAGE DIAGNOSIS THAT THE CAGE WAS GRADUALLY SHRINKING. IT IS CLAIMED THAT EVERY TWO WEEKS IT IS PHOTOGRAPHED, AND GRADUALLY IT IS CLOSING. THE CAGE IS CURRENTLY BEING BACKED OUT, THE REPORTED ANOTHER COMPANY'S SCREW DID NOT CAUSED/CONTRIBUTED FOR FAILURE OF CAGE. THE CURRENT SYMPTOMS ARE CALM AND THERE ARE NO PLANS FOR REVISION SURGERY. THE PATIENT NUMBNESS WAS LIKELY RELATED TO CAGE BACK OUT. THE PROCEDURE OR TECHNIQUE PERFORMED WAS MISTLIF OF L4/5 AND THE LEVELS IMPLANTED WERE L4/L5

  Patient problems: Numbness

  MAUDE report 15263900 ↗