Catalyft PL Expandable Interbody System 6069076Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00763000246792), received between Sep 9, 2022 and Jul 7, 2026 — classified as 7 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (35 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Difficult or Delayed Positioning; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR L3-5 SCREWS WITH L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH CATALYFT CAGES. IT WAS REPORTED THAT UPON INSERTION OF THE CAGE THE SURGEON ATTEMPTED TO EXPAND BUT THEEXPANSION DRIVER DID NOT ENGAGE AND WAS FREELY SPINNING. UNABLE TO EXPAND, SURGEON REMOVED THE CAGE AND IT WAS CHECKED FOR ANY ISSUES. USING THE EXPANSION DRIVER THE SCRUB NURSE WAS ABLE TO SUCCESSFULLY OPEN AND CLOSE THE CAGE. THE CAGE WAS THEN IMPLANTED A SECOND TIME; AND YET AGAIN THE TIP OF THE DRIVER WAS UNABLE TO ENGAGE WITH THE CAGE. THE DECISION WAS THEN MADE TO DISENGAGE THE CAGE FROM THE INSERTER TO FURTHER TROUBLESHOOT. UNFORTUNATELY, WHEN LATER TRYING TO RETHREAD THE CAGE ONTO THE REVISION SLEEVE THE CAGE MIGRATED ANTERIORLY AND BREACHED THE ANTERIOR DISC SPACE. DUE TO THE DANGEROUS POSITION, ONE AND HALF HOURS WAS LOST TRYING TO REVERSE THE CAGE WITH VARIOUS TOOLS AS THE REVISION SLEEVE COULD NOT BE ATTACHED. AFTER THE DELAY, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PULL THE CAGE BACK OUT ENTIRELY, TRIED EXPANDING AND COLLAPSING THE CAGE THEMSELVES AND THEN WERE ABLE TO REP OSITION AND INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729848 ↗
• InjuryJan 5, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY FOR DISC HERNIATION. LEVELS INVOLVED WAS L3-4. IT WAS REPORTED THAT THE CAGE APPEARED COLLAPSED AND HALF WAY OUT OF DISC SPACE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT CAGE BACKED OUT, REVISION SURGERY WITH REMOVAL OF CAGE WAS PERFORMED WITH NEW INSTRUMENTATION FROM L2-L5. DISC SPACE WAS TOO LARGE TO PUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955297 ↗
• InjuryJul 3, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION THERAPY FOR SPINAL CANAL STENOSIS. LEVELS INVOLVED WAS L5-S1. IT WAS REPORTED THAT THE POSTOPERATIVE JACK DOWN. PATIENT EXPERIENCED BONE FUSION FAILURE AND INSTABILITY, WHICH LED TO REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE IMPLANT POSITION REMAINED INTACT, AND THE OPEN CAGE SHRANK. RE-SURGERY WAS PERFORMED DUE TO INSTABILITY, THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT INSTABILITY DEVELOPED DUE TO BONE FUSION FAILURE AND ROD BREAKAGE AFTER JACKING DOWN, SO A DIFFERENT CAGE WAS INSERTED AND THE ROD WAS RE-FASTENED FOR RE-SURGERY. THERE WERE NO PATIENT SYMPTOMS DEVELOPED AFTER RE-SURGERY. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ROD BREAKAGE OCCURRED ON L5-S1.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22392404 ↗
• MalfunctionJun 25, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE CAGES JACKED DOWN. NO PLAN FOR ADDITIONAL SU RGERY. 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 22326511 ↗
• MalfunctionJun 19, 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 IDENTIFIED AT POST-OP 6 MONTH FOLLOW UP. PROCEDURE PERFORMED WAS L3-5 (TLIF) T RANSFORAMINAL LUMBAR INTERBODY FUSION. THE LEVELS IMPLANTED WERE 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 22288804 ↗
• 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 IDENTIFIED AT POST-OP 6 MONTH FOLLOW UP. PROCEDURE PERFORMED WAS L3-L4 LAMINECTOMY AND L4-L5 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 22274175 ↗
• MalfunctionJun 17, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD OPEN TRANSFORA MINAL 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22220701 ↗
• MalfunctionJun 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) PROCEDURE AT THE L2-S1 LAMI L4/5 LEVELS. IT WAS REPORTED THAT THE CAGE COLLAPSED AT L4-5 LEVEL. IT WAS REPORTED THAT THE CATALYFT CAGE WAS COLLAPSED. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200883 ↗
• MalfunctionJun 5, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION FOR LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT THE CAGE JACKED DOWN AFTER SURGERY. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148405 ↗
• MalfunctionMar 27, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED IN TLIF THERAPY FOR L5/S STENOSIS. LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT THE CY, WHICH HAD EXPANDED AND COMPLETED, WAS CLOSED BASED ON THE IMAGING TWO MONTHS AFTER THE L5/S TLIF. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT NO ADDITIONAL SURGERY WAS PERFORMED, NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704588 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CATALYFT PL40 SPACER. IT WAS REPORTED THAT THE CAGE HAD COLLAPSED AFTER ABOUT 6-7 MONTHS SINCE THE CAGE WAS IMPLANTED AND EXPANDED. NO ADDITIONAL SURGERY HAS BEEN PERFORMED. THE PROCEDURE THAT WAS DONE WAS A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650098 ↗
• MalfunctionMar 13, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF AND PPS FOR LCS. IT WAS REPORTED THAT AFTER ONE WEEK OF THE PROCEDURE, THE SPACER THAT HAD EXPAND WAS CLOSED. AFTER THE PROCEDURE, THE SPACER THAT HAD EXPAND WAS CLOSED. PRODUCT REMAINS IN PATIENT. THERE WERE NO ADDITIONAL SURGERY OR TREATMENT PERFORMED/PLANNED DUE TO THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591555 ↗
• MalfunctionMar 4, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL INTERBODY LUMBAR FUSION(TLIF) FOR LUMBAR CANAL STENOSIS (LCS). LEVEL AT WHICH THE IMPLANT WAS PERFORMED: L4/S2. IT WAS REPORTED THAT CAGE CONTRACTION OCCURRED IN TWO OF THE TWO INTERVERTEBRAL FUSIONS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO DELAY IN THE OVERALL PRO CEDURE TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE IS NO PLAN TO PERFORM THE ADDITIONAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED THAT CONTRACTION OF THE CAGE PLACED IN BETWEEN L5/S AND L4/5 WAS CONFIRMED. REPEAT SURGERY IS NOT SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512118 ↗
• MalfunctionMar 2, 2025Mechanics Altered; Mechanics Altered

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500934 ↗
• MalfunctionMar 2, 2025Mechanics Altered; Mechanics Altered

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500883 ↗
• MalfunctionFeb 26, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH CATALYFT SPACER SUFFERING FROM STENOSIS. IT WAS REPORTED THAT THE JACK-UP OF CATALYFT HAS RETURNED DURING FOLLOW UP OBSERVATION. THE JACK-UP OF THE CATALYLT HAS MOVED TO THE INITIAL PLACE. THERE WAS NO DAMAGE TO THE CAGE OBSERVED. PRODUCT STILL IMPLANTED INSIDE THE PATIENT AND CURRENTLY THEIR IS NO PLAN TO EXPLANT IT. ONLY JACK-UP OF THE IMPLANT DEVIATED INSIDE THE PATIENT. IN THIS PRODUCT, WHICH HAS A JACK-UP MECHANISM, THE JACK-UP MECHANISM WAS NOT RETAINED FOR SOME REASON, SO THE ANGLE OF THE CAGE COULD NOT BE MAINTAINED. THE PATIENT HAS NOT RECOVERED FROM THE AILMENTS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467435 ↗
• MalfunctionFeb 23, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN L3/5 TLIF FOR AN L3/5 LCS WITH KYPHOSIS. IT WAS REPORTED THAT DURING L4/5 TLIF, AFTER THE CAGE WAS INSERTED, THE INSERTER DRIVER WAS INSERTED BUT IT DID NOT FIT THE CAGE WELL. THE SURGEON GAVE UP AFTER TRYING SEVERAL TIMES. IT BARELY FIT BUT WAS IDLING SOON. ONCE REMOVED, THE AUTOLOGOUS BONE THAT HAD BEEN PREVIOUSLY PACKED IN THE INTERVERTEBRAL DISC SPACE HAD ENTERED THE CAGE AND HAD ALSO ENTERED THE SCREWS INSIDE THE CAGE. IT WAS AGREED THAT THE INSERTER DRIVER DID NOT FIT. AFTER THAT, A NEW CAGE WAS INSERTED AND THERE WERE NO PROBLEMS. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS UNKNOWN IF THE PATIENT NEED TO BE HOSPITALIZED OR STAYED LONGER. THERE WAS A LESS THAN 60 MINUTE DELAY IN OVERALL PROCEDURE TIME. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442024 ↗
• MalfunctionJan 17, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (REGULATORY BODY, HEALTHCARE PROFESSIONAL, MANUFACTURER REPRESENTATIVE) REGARDING A P ATIENT WHO WAS IMPLANTED WITH EXPANDABLE INTERBODY DEVICE. IT WAS REPORTED THAT DURING POSTOPERATIVE X-RAY FOLLOW-UP EXAMINATIONS ON (B)(6) 2024, IT WAS OBSERVED DURING THAT THERE WAS A POSTOPERATIVE LOSS OF THIS HEIGHT EXPANSION. THE IMPLANT LOST THE HEIGHT IT HAD GAINED / CAGE COLLAPSED. THERE WAS NO PATIENT SYMPTOMS REPORTED. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH DORSAL INSTRUMENTATION. THERE WAS NO IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED OR PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177805 ↗
• InjuryJul 10, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REVISION SURGERY TO REMOVE THIS CAGE HAS BEEN PERFORMED (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708114 ↗
• MalfunctionJul 4, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L5/STLIF DUE TO L5/S SPINAL CANAL STENOSIS. IT WAS REPORTED THAT L5/STLIF WAS PERFORMED ON (B)(6) 2023.13(USING CY PL40). AFTER THAT, THE EXPANDED CAGE WAS FOUND TO BE CLOSED ON (B)(6) 2024. THE CAUSE OF THE CAGE BEING CLOSED IS ALSO UNKNOWN. 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 19675784 ↗
• MalfunctionJun 14, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DISC HERNIATION OR LUMBAR INTERVERTEBRAL STENOSIS. IT WAS REPORTED THAT THE V5 SET SCREW DISLODGED AFTER SURGERY AND REINSTALLATION OCCURRED. THE CAGE COULD NOT BE REMOVED AT THE TIME OF REPEAT SURGERY, SO IT WAS PLACED STILL CONTRACTED (WHILE CONTINUED TO BE USED). THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE CAGE CONTRACTION, SO THERE ARE NO PLANS TO REMOVE IT AT THAT POINT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537735 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPACER HAVING L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THERE WAS A CONTRACTION OF IMPLANTED CAGE. IN THE INITIAL SURGERY, INTRAOPERATIVE TECHNIQUE WAS APPROPRIATE AND TRIAL SIZE SELECTION WAS MADE. OPENING WAS PERFORMED UP TO THE CY TORQUE LIMIT AND COMPRESSION WAS ALSO PERFORMED AT THE END. THE CAGE WAS BELIEVED TO BE LOADED TO A REASONABLE DEGREE BY THE END PLATE. IMPLANT REMAINS IN PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. PATIENT IS RECOVERING FROM ITS AILMENTS THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO REVISION SURGERY OCCURRED/ PLANNED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19334880 ↗
• MalfunctionApr 30, 2024Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED. NO REVISION SURGERY WAS PERFORMED TO EXPLANT THE COLLAPSED CAGE.

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

  MAUDE report 19210960 ↗
• MalfunctionApr 28, 2024Mechanical 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 WAS USED FOR INTERVERTEBRAL FUSION (TLIF), HOWEVER, CAGE CONTRACTION WAS OBSERVED DURING POSTOPERATIVE FOLLOW-UP. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION DONE AS A RESULT OF THIS EVENT. THERE IS NO PLAN TO EXPLANT THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199030 ↗
• MalfunctionFeb 26, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN T RANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L5/S1 STENOSIS. LEVELS IMPLANTED WAS L5/S1. IT WAS REPORTED THAT THE CAGE WAS CONTRACTED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776349 ↗