Catalyft PL Expandable Interbody System 6068073Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00763000246693), received between Oct 12, 2022 and Feb 10, 2026 — classified as 21 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (43 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 18, 2026.

Recalls naming this device

1. Sep 16, 2025Class IIOpen, 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BIOTH THE CAGES IMPINGED ONTO UPPER ENDPLATE OF L4/5 DISC PATIENT REPORTED CRAMPING LEG . THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24302453 ↗
• MalfunctionFeb 10, 2026Migration

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE PROCEDURE INVOLVED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4/5. NO REVISION SURGERY PLANNED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24302396 ↗
• MalfunctionJan 20, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST L5/S PLIF. IT WAS REPORTED THAT AT L5-S1 ON (B)(6), JACK DOWN OF THE CAGE WAS DISCOVERED DURING THE PATIENT'S OUTPATIENT EXAMINATION. 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 24112879 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6)) L2-L5 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). PATIENT MEDICAL HISTORY: CHRONIC PAIN, LOWER URINARY TRACT INFECTIOUS DISEASE, OBESITY, PRIMARY OSTEOARTHRITIS OF LEFT HIP, SCOLIOSIS OF LUMBAR SPINE, UNSPECIFIED SCOLIOSIS TYPE. INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 FOR WOUND IRRIGATION AND DEBRIDEMENT. IT WAS REPORTED THAT PATIENT HAD WOUND INFECTION AFTER SURGERY WITH SPECIFIC SYMPTOMS OF WOUND DISCHARGE AND VISIBLE DEHISCENCE CAUSING WOUND IRRIGATION AND DEBRIDEMENT PROCEDURE WITH HOSPITALIZATION. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE RELATED ASSESSMENT, EVENT WAS POSSIBLY RELATED TO DEVICE AND CAUSALLY RELATED TO STUDY PROCEDURE. MRI WAS DONE WHICH SHOWED FLUID COLLECTION AND SURGICAL WOUND INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23815664 ↗
• InjuryDec 8, 2025Mechanical Problem; Mechanical Problem

  ADDITUIONAL INFORMATION RECEIVED: THE CAGE WAS EXPLANTED ON DEC/4TH IN THE RESURGERY.

  Patient problems: Nerve Damage

  MAUDE report 23739595 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, PATIENT UNDERWENT A FUSION 1 LEVEL AT L4-L5. THE CAGE WAS IMPLANTED AND WAS FULLY EXPANDED WITH THE TORQUE LIMITED HANDLE. AFTER 3 MONTHS THE PATIENT UNDERWENT A FOLLOW UP X-RAY AND THE SURGEON SAW THAT THE CAGE HAD COLLAPSED AND SLIGHTLY MOVED TO THE LEFT. THE SURGEON IS NOT PLANNING TO MAKE ANY OTHER ACTIONS THAN A FOLLOW UP X-RAY EVERY MONTH. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691222 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVAS IVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT AT THE 30 DAY POST IMAGING APPOINTMENT, THE DEVICE WAS DISCOVERED TO HAVE RETRO-PULSED FROM ITS ORIGINAL OPERATIVE POSITION. 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 23355256 ↗
• MalfunctionSep 23, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN OF REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REVISION SURGERY WAS PERFORMED DUE TO ADJACENT SEGMENT DISEASE BUT REPORTED DEVICES WERE NOT EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ONLY ONE OF 2 CAGES WAS CONTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23120038 ↗
• InjurySep 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPACER HAVING SPINAL THERAPY FOR ROD FRACTURE. IT WAS REPORTED THAT BONE FUSION HAD NOT OCCURRED BECAUSE THE CAGE SHIFTED IMMEDIATELY AFTER THE SURGERY. IT IS UNKNOWN WHETHER THE ISSUE IS DUE TO THE JACK-DOWN OF CY OR THE ABSENCE OF SCREW INSERTION INTO S, AND THE LACK OF COMPRESSION AT L5-IL, BUT IT WAS BACKING OUT. SINCE RE-FIXATION IS REQUIRED, THE HOSPITALIZATION WOULD BE EXTENDED BY APPROXIMATELY ONE MONTH. REVISION SURGERY WAS PERFORMED TO EXPLANT THE CAGE. THE EXPLANTED CAGE HAD NO DAMAGE AND JACK-UP COULD BE DONE. LEVELS IMPLANTED FOR THE MIGRATED CAGE WAS L5/S. 1 CAGE WAS ALSO INSERTED INTO L2/3, THE 2 CAGES WERE USED FOR L5/S. ONE OF THE TWO PLACED AT 5/S, ONE BACKED OUT. THE ONE PLACED AT L2/3 JACK-DOWNED. BOTH WERE REMOVED, AND AUTOLOGOUS ILIAC BONE GRAFTING WAS PERFORMED. THE OTHER ONE AT 5/S HAS NO ISSUES AND REMAINS IN PLACE. THIS EVENT WAS A REPEAT SURGERY AND NO MEDTRONIC PRODUCT INVOLVED IN INITIAL SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23081956 ↗
• InjurySep 18, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPACER HAVING SPINAL THERAPY FOR ROD FRACTURE. IT WAS REPORTED THAT BONE FUSION HAD NOT OCCURRED BECAUSE THE CAGE SHIFTED IMMEDIATELY AFTER THE SURGERY. IT IS UNKNOWN WHETHER THE ISSUE IS DUE TO THE JACK-DOWN OF CY OR THE ABSENCE OF SCREW INSERTION INTO S, AND THE LACK OF COMPRESSION AT L5-IL, BUT IT WAS BACKING OUT. SINCE RE-FIXATION IS REQUIRED, THE HOSPITALIZATION WOULD BE EXTENDED BY APPROXIMATELY ONE MONTH. REVISION SURGERY WAS PERFORMED TO EXPLANT THE CAGE. THE EXPLANTED CAGE HAD NO DAMAGE AND JACK-UP COULD BE DONE. LEVELS IMPLANTED FOR THE MIGRATED CAGE WAS L5/S. 1 CAGE WAS ALSO INSERTED INTO L2/3, THE 2 CAGES WERE USED FOR L5/S. ONE OF THE TWO PLACED AT 5/S, ONE BACKED OUT. THE ONE PLACED AT L2/3 JACK-DOWNED. BOTH WERE REMOVED, AND AUTOLOGOUS ILIAC BONE GRAFTING WAS PERFORMED. THE OTHER ONE AT 5/S HAS NO ISSUES AND REMAINS IN PLACE. THIS EVENT WAS A REPEAT SURGERY AND NO MEDTRONIC PRODUCT INVOLVED IN INITIAL SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23081882 ↗
• MalfunctionSep 8, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CATALYFT CAGE COULD NOT EXPAND. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994213 ↗
• InjuryMay 27, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE IMPLANTS WERE MIGRATED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085697 ↗
• MalfunctionMay 1, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS LUMBAR SPONDYLOLISTHESIS AT L4-L5. IT WAS REPORTED THAT, THE PATIENT HAD SURGERY ON (B)(6) 2024 UTILIZING VOYAGER 4.75 FOR POSTERIOR FIXATION AND CATALYFT PL FOR INTERBODY FUSION AT L4-L5 POSTERIOR LUMBAR INTERBODY FUSION. DURING THE PATIENT'S 3 MONTH POST OP VISIT, IT WAS NOTED IN THE X-RAY FILMS THAT THE CATALYFT PL EXPANDABLE INTERBODY COLLAPSED. IT WAS JUST OVER 4 MONTHS POST OPERATIVE; HENCE, PATIENT DID NOT ACHIEVE SOLID FUSION. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE COLLAPSED CAGE. THERE IS NO CURRENT PLAN TO EXPLANT THE COLLAPSED CAGE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940952 ↗
• InjuryApr 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 THE CAGE COLLAPSED AND CAUSED IT TO BACK OUT THERE WAS PAIN FROM INTERBODY PUSHING ON NERVES AND STENOSIS. THE DEVICE WAS EXPLANTED AS A RESULT.

  Patient problems: Pain; Stenosis

  MAUDE report 21932176 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF SPINAL THERAPY. LEVEL AT WHICH IMPLANT WAS PERFORMED IS L3/5. IT WAS REPORTED THAT THE CAGE IS CONTRACTED AND SCREW LOOSENING HAPPENED. THE CONDITION HAD PROGRESSED TO PSEUDOARTHROSIS. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE SCREW WITH LOOSENING OCCURRED IN SOLERA5.5/6.0 PRODUCT

  Patient problems: Inadequate Osseointegration

  MAUDE report 21909863 ↗
• MalfunctionMar 24, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS DEGENERATIVE DISC DISEASE (DDD). LEVELS IMPLANTED WAS 4/5. IT WAS REPORTED THAT THE CATALYFT PL CAGE COLLAPSED AND LOST HEIGHT MANY YEARS AFTER IMPLANTATION. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676342 ↗
• MalfunctionMar 19, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPACER HAVING L3-4 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR DEGENERATIVE DISC DISEASE/SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING A FOLLOW-UP CLINIC VISIT, THE CATALYFT CAGE WAS FOUND TO HAVE COLLAPSED AND MIGRATED POSTERIORLY. THE SURGEON REVIEWED THE SIX-MONTH POST-OPERATIVE IMAGES AND NOTED THESE ISSUES, ALTHOUGH THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE VISIT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AT THE TIME OF SURGERY. AT TIME OF 6 MONTH FOLLOW UP, PATIENT IS STABLE BUT CAGE HAD MIGRATED POSTERIORLY AND COLLAPSED A FEW MM. THERE WAS NO REVISION SURGERY REPORTED / OCCURRED AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639963 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CATALYST IMPLANT WAS INTRODUCED A FEW MONTHS AGO (B)(6) 2024) AND THE REVISION SHOWED THAT THE CAGE HAS COLLAPSED AND THE EXPANSION IS NOT THE SAME AS WHEN IT WAS INSERTED DURING SURGERY. THE INITIAL HEIGHT HAS NOT BEEN MAINTAINED AND THIS HAS CAUSED PROBLEMS IN THE PATIENT'S LORDOSIS AND DISCOMFORT AFTER IMPLANTATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN/SCHEDULE FOR THE REVISION SURGERY.

  Patient problems: Discomfort

  MAUDE report 21603796 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, THE CATALYFT BREAK IN. IT WAS UNKNOWN ABOUT THE PATIENT SYMPTOMS OR COMPLICATIONS. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT CAGE HEIGHT COLLAPSE, NO REVISION SURGERY TO EXPLANT THE CAGE. PATIENT HAD POST OPERATIVE BACK PAIN.

  Patient problems: Pain

  MAUDE report 21585593 ↗
• MalfunctionMar 12, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION FOR LATERAL SLIPPING SYNDROME. IT WAS REPORTED THAT AFTER INSERTION OFTHE CAGE, THE POSITION OF THE CAGE WAS POOR, SO AN ATTEMPT WAS MADE TO REMOVE THE CAGE AFTER CLOSING IT, BUT THE CAGE DID NOT COMPLETELY CLOSE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581707 ↗
• MalfunctionMar 5, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE HA VING L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE COLLAPSED BETWEEN THE 3-MONTH AND 6-MONTH X-RAYS DURING PATIENT FOLLOW-UP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO REVISION SURGERY OCCURRED / PLANNED AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523023 ↗
• MalfunctionFeb 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION L4/5 FOR LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT THE DRIVER BROKE WHEN AN ATTEMPT WAS MADE TO EXPAND THE CAGE. THE TIP OF THE INSERTER DRIVER BROKE WHEN THE CAGE WAS EXPANDED. ONE SIDE OF THE CAGE IN THE FACILITY WAS EXPANDED TO THE LEFT AND RIGHT AT THE SAME TIME. AS SUCH, THE CAGE WAS REMOVED. THE CAGE AND THE DRIVER WERE REPLACED WITH A NEW ONE AND INSTALLED. THERE WAS A POSSIBILITY OF SCREWDRIVER DETERIORATION AND A POSSIBILITY THAT THE CAGE HAS A DEFECT (BECAUSE THE REMOVED CAGE MOVED AROUND/WAS LOOSE). THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. 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 21444839 ↗
• InjuryFeb 20, 2025Off-Label Use; Off-Label Use

  ADDITIONAL INFORMATION RECEIVED STATES THAT, THERE WAS NO PLAN OF REVISION SURGERY TO EXPLANT THE CAGES. NO FURTHER COMPLICATIONS RE PORTED.

  Patient problems: Paralysis; Unspecified Nervous System Problem

  MAUDE report 21419643 ↗
• InjuryFeb 20, 2025Off-Label Use; Off-Label Use

  ADDITIONAL INFORMATION RECEIVED STATES THAT, THERE WAS NO PLAN OF REVISION SURGERY TO EXPLANT THE CAGES. NO FURTHER COMPLICATIONS RE PORTED.

  Patient problems: Paralysis; Unspecified Nervous System Problem

  MAUDE report 21419568 ↗
• MalfunctionFeb 11, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST TLIF PROCEDURE. IT WAS REPORTED THAT HEIGHT OF THE PRODUCT COLLAPSED. 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 21353122 ↗