Catalyft PL Expandable Interbody System 6068093Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000246723), received between Jan 24, 2022 and May 11, 2026 — classified as 11 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CATALYFT CAGE USED IN ANTERIOR LUMBAR INTERBODY FUSION AT LEVELS L4¿5. IT WAS REPORTED THAT DURING IMAGING CHECK UP, THE PHYSICIAN FOUND OUT THAT THE CAGE HAD COLLAPSED AND MIGRATED POSTERIORLY, THREE MONTHS POST-OPERATIVELY. THE PATIENT WAS ASYMPTOMATIC AT THE EVENT. A REVISION SURGERY, ALIF L4-5 AND REMOVAL OF CATALYFT CAGE WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAGE WAS IMPLANTED IN A PROCEDURE OF TLIF(TRANSFORAMINAL LUMBAR INTERBODY FUSION.) AND ALIF( ANTERIOR LUMBAR INTERBODY FUSION AT LEVELS L4¿5 WAS THE REVISION SURGERY. THE MALFUNCTION WAS OBSERVED THROUGH IMAGING BY THE PHYSICIAN JUST BEFORE THE REVISION SURGERY DURING PATIENT'S THREE MONTH FOLLOW-UP. THE CAGE WAS EXPLANTED DURING THE REVISION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144822 ↗
• InjuryMar 12, 2026Mechanical Problem; Use of Device Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE CAGE COLLAPSED BY A FEW MILLIMETERS AND CAUSED IT TO MOVE WITHOUT ANY HARM TO THE PATIENT. SURGEON SAYS THAT WHEN THE CAGE IN QUESTION WAS IMPLANTED, HE DID NOT PERFORM THE PRACTICE OF MAKING THE TORQUE HANDLE CLICK AS AT THAT TIME, IT WAS NOT YET INDICATED AS BEING REQUIRED. LEVELS IMPLANTED WERE L5-S1. REVISION SURGERY WAS PERFORMED AND THE CAGE WAS EXPLANTED. THERE WAS NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578856 ↗
• InjuryNov 6, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, CATALYFT PL 9MM SHORT WAS IMPLANTED DURING A CASE ON (B)(6) 2025 EXPANSION WAS PERFORMED USING A "TWO FINGER" TECHNIQUE TO MINIMIZE SUBSIDENCE FORCES. IMPLANTATION WAS UNREMARKABLE AND DONE ACCORDING TO SURGICAL TECHNIQUE. PHYSICIAN NOTIFIED REP ON (B)(6) 2025 ABOUT REVISION SURGERY ON THIS PATIENT TO REVISE CATALYFT CAGE, WHICH HAD RETROPULSED AND IT WAS IMPINGING IN SPINAL CANAL. REVIEW OF IMAGING SHOWED THAT THE CAGE WAS NOT POSITIONED AS ANTERIORLY AS IT SHOULD HAVE BEEN. IT ALSO APPEARS THAT THE CAGE DID NOT COLLAPSE IN-SITU. PROCEDURE PERFORMED WAS RIGHT SIDED TRANSFORAMINAL LUMBAR INTERBODY FUSION. RETROPULSED CAGE WAS REMOVED AND A SHORT 9MM PL40 WAS PUT IN ITS PLACE. PATIENT SUFFERED LEFT SIDED LEG PAIN AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Neuralgia

  MAUDE report 23484415 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Site Seriousness Assessment: Severity of AE is severe.

  Patient problems: Neuropathy; Spinal Column Injury

  MAUDE report 23287364 ↗
• 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 22085676 ↗
• MalfunctionApr 21, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE INVOLVING THE CATALYST SPACER, THE IMPLANT WOULD NOT EXPAND. THE PRODUCT WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT SYMPTOMS/ COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875209 ↗
• InjuryMar 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING REVISION SURGERY. IT WAS REPORTED THAT ON JANUARY 17TH, AN L4-S POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED. IN FEBRUARY, THE CATALYFT BACKED OUT, AND ON FEBRUARY 19TH, IT WAS REMOVED AND AN AUTOLOGOUS BONE GRAFT WAS PERFORMED. IT IS POSSIBLE THAT THE BACKING OUT OCCURRED DUE TO DAMAGE TO THE POSTERIOR WALL OF THE VERTEBRAL BODY. 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 21603846 ↗
• MalfunctionMar 4, 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 CATALYFT BROKE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE CAGE HAS LOST HEIGHT. THERE IS NO PLAN/SCHEDULE FOR REVISION SURGERY.

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

  MAUDE report 21512272 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LEVEL 4/5 TRANS FORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR AN INDICATION OF OSTEOCHONDROSIS L4/5 AND BILATERAL RECESS STENOSIS L4/5. IT WAS REPORTED THAT THE POST-OP MEASUREMENTS OF THE IMAGES FROM (B)(6) 2024 AND (B)(6) 2024 AND IT SHOWS THAT THE ORIGINAL DISTRACTION OF THE CATALYFT CAGE HAS DIMINISHED IN THE FOLLOW-UP IMAGING. THERE WAS DISTRACTION LOSS FROM 13.7 TO 12.1 MM DATED (B)(6) 2024 AND LORDOSIS CONSTANT AT 23°. ON (B)(6) 2024, THE CAGE WAS 12MM AND LORDOSIS WAS AT 23°. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2024 AND LOSS OF DISTRACTION OF THE CAGE WAS FIRST NOTICED ON (B)(6) 2024. THE REVISION SURGERY WAS CURRENTLY NOT PLANNED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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

  MAUDE report 21290419 ↗
• MalfunctionJan 28, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED. PATIENT HAD POST OPERATIVE BACK PAIN.

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

  MAUDE report 21251482 ↗
• MalfunctionJan 28, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN/SCHEDULE FOR THE REVISION SURGERY. PATIENT SYMPTOMS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249737 ↗
• MalfunctionJan 2, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT NO REVISION SURGERY HAS BEEN SCHEDULED OR PLANNED FOR THE REMOVAL OF SUBSIDED CAGE AT L4-L5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053079 ↗
• InjuryNov 26, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR F IXATION FOR ROD FRACTURE AND RE-ANCHORING. LEVELS IMPLANTED AT TH11-S2AI. IT WAS REPORTED THAT AFTER FINAL FASTENING, WHEN ATTEMPTING TO REMOVE THE PRODUCT, IT COULD NOT BE DETACHED FROM THE SCREW HEAD DESPITE THE LOCK BEING RELEASED. IT IS BELIEVED THAT THE ADJACENT EXTENDER BODY INTERFERED, LEAVING NO SPACE TO MOVE THE EXTENDER EVEN WITH THE LOCK RELEASED, CAUSING IT TO GET STUCK AND NOT DETACH. A PART OF THE TIP WAS DAMAGED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT POST-OPERATIVE INFECTION WAS CONFIRMED AFTER THE INITIAL SURGERY AND CLEANING WAS PERFORMED. THE DATE OF ONSET IS UNKNOWN; NO IMPLANT MALFUNCTIONS WERE CONFIRMED AT THIS TIME. AFTERWARDS, LEFT ROD FRACTURE, LOOSE SET SCREWS IN THE RIGHT SACRAL ILIAC, AND BACKOUT OF THE L5/S CAGE WERE CONFIRMED, AND REPEAT SURGERY WAS PERFORMED ON (B)(6) 2024. NO PATIENT SYMPTOMS ARE ASSOCIATED WITH THE MALFUNCTION. SCREW WAS ADDED FOR POSTOPERATIVE INFECTIONS. NO DEFECTS I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783331 ↗
• MalfunctionOct 21, 2024Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT IS USED FOR POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492132 ↗
• MalfunctionOct 16, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF. IT WAS RE PORTED THAT THE CATALYFT USED IN PLIF WAS JACKED DOWN. UPON CHECKING THE CONTENTS, CLEAR JACKDOWN WAS OBSERVED IN COMPARISON WITH THE X-RAY IMAGES IMMEDIATELY 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 20461907 ↗
• MalfunctionOct 14, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN CLINICAL STUDY NAME TLIF IDE PIVOTAL STUDY (B)(6), CLINICAL PATIENT ID (B)(6). IT WAS REPORTED THAT THE PATIENT HAD LEFT LATERAL LOWER LEG PARESTHESIA, ABNORMAL NEURO LUMBAR EXAM S1 IMPAIRED LEFT SIDE TO LIGHT TOUCH AND PIN PRICK. SEVERITY OF ADVERSE EVENT IS MODERATE. PATIENT HAD NUEROLOGICAL STATUS LUMBAR PHYSICAL EXAM WAS CONDUCTED ON (B)(6) 2024 WHICH RESULTED IN IMPAIRED SENSORY FUNCTION LEFT S1 TO LIGHT TOUCH AND PIN PRICK. PRINCIPAL INVESTIGATOR REVIEWED THE IMAGING AND STATED THESE DEMONSTRATE INTACT HARDWARE POSTERIORLY L4-S1. IT APPEARS SHE HAS SUBSIDED SLIGHTLY AT L4-L5 AS COMPARED TO HER IMMEDIATE POSTOPERATIVE X-RAYS. INVESTIGATOR ASSESSED THAT THE EVENT HAS CAUSAL RELATIONSHIP WITH STUDY PROCEDURE (L4-S1 TLIF), UNLIKELY RELATED TO TLIF GRAFTING MATERIAL, POSSIBLE RELATED TO INTERVERTEBRAL BODY FUSION DEVICE AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. SPONSOR ASSESSED THAT THE EVENT HAS CAUSAL RELATIONSHIP WITH STUDY PROCEDURE (L4-S1 TLIF), UNLIKELY RELATED TO TLIF GRAFTING MATERIAL, POSSIBLE RELATED TO INTERVERTEBRAL BODY FUSION DEVICE AN

  Patient problems: Paresthesia

  MAUDE report 20442671 ↗
• MalfunctionMay 11, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE LAMINECTOMY AND DISCECTOMY. IT WAS REPORTED THAT THE CAGE HAD MIGRATED AND SETTLED 2-3MM MORE POSTERIORLY THAN INITIALLY IMPLANTED. IMPLANT REMAINS IN PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED ANTICIPATE. PROCEDURE USED IN THIS EVENT WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR DEGENERATIVE DISC DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19295054 ↗
• InjuryApr 8, 2024Adverse 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 A PATIENT HAVING CLINICAL ID (B)(6). IT WAS REPORTED THAT CT POSTOP SHOWED VERTEBRAL BODY FRACTURE INTERVENTIONS ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: N IF SUBJECT HOSPITALIZED, IS IT A PROLONGATION (>24 HOURS) OF AN EXISTING HOSPITALIZATION: N ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: Y OTHER ACTION TAKEN: L50 RIGID BRACE ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT ACTION RESULT: N DIAGNOSTICS ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: CT WITHOUT CONTRAST1 ACTION RESULT: LUMBAR FRACTURE ACTION DATE: (B)(6) 2023 ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED ACTION RESULT: Y SITE RELATED ASSESSMENT: CAUSAL RELATIONSHIP TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM AND NOT RELATED TO TLIF GRAFTING MATERIAL, PROCEDURE AND CAPSTONE PEEK SPINAL SYSTEM IMPLANT. ON (B)(6) 2024, UPDATE RECEIVED ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: Y ACTION DATE: ON (B)(6)2023 END DATE OF THE HOSPITALIZATION: ON (B)(6) 2023 IF SUBJECT HOSPITALIZED, IS IT A PROLONGATION (>24HOURS) OF AN EXISTING HOS

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19058293 ↗
• InjurySep 26, 2023Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY DUE TO CAGE MIGRATION. IT WAS REPORTED THAT CAGE HAS BEEN MIGRATED DORSALLY, LOOSING CONTACT TO ENDPLATES AND THERE IS A RISK OF NE UROLOGICAL DAMAGE.  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 17816626 ↗
• MalfunctionMay 11, 2023Product Quality Problem; Mechanics Altered; Product Quality Problem; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR LUMBAR INTERBODY FUSION (PLIF) FOR DEGENERATIVE SPONDYLOLISTHESIS. IT WAS REPORTED THAT CAGE SHRINK SLIGHTLY WHEN IT WAS PRESSED DOWN WITH A FINGER. LEVELS IMPLANTED L4/5. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PRODUCT CAME IN CONTACT WITH PATIENT AND THE EVENT WAS OBSERVED IMMEDIATE AFTER OPENING THE DELIVERED BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16909348 ↗
• MalfunctionOct 21, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN TRANSFO RAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY. IT WAS REPORTED THAT THE THE CAGE HAS COLLAPSED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF COLLAPSED CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15648376 ↗
• InjuryAug 18, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPO RTED PRODUCT. IT WAS REPORTED THAT, CAGE WAS BACKED OUT 13MM POST-OP, IMAGING SHOWING THE CAGE BACKED OUT WAS TAKEN ON (B)(6) 2022. REVISION WAS PERFORMED TO EXPLANT THE REPORTED CAGE AND THE CAGE WAS DISCARDED AT USER FACILITY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15247312 ↗
• MalfunctionJul 14, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN ONE LEVEL TLIF AT L4-5. IT WAS REPORTED THAT AT 5-MONTH FOLLOW UP, IT WAS NOTICED THAT THE CAGE HAD COLLAPSED. THERE IS NO REVISION PLANNED TO REMOVE IT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT IS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011450 ↗
• InjuryJan 24, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- DEGENERATIVE DISC DISEASE/ RADICULOPATHY INVOLVED IN THE TLIF PROCEDURE. LEVELS IMPLANTED: L5-S1. IT WAS REPORTED THAT DURING PROCEDURE, THE CATALYFT INTERBODY CAGE MIGRATED ANTERIOR (VENTRAL) TO THE L5-S1 DISC SPACE PAST THE ANTERIOR LONGITUDINAL LIGAMENT ENDING UP IN THE PATIENT¿S RETROPERITONEAL CAVITY. THE CAGE WAS THEN RETRIEVED THROUGH AN ANTERIOR APPROACH TO THE PATIENT¿S SPINE. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PATIENT IS ALIVE AND NO INJURY. ADDITIONAL SURGERY WAS PERFORMED. THE INTERBODY CAGE PLACED IN THE L5-S1 DISC SPACE FROM A POSTERIOR TLIF APPROACH MIGRATED PAST THE ANTERIOR LONGITUDINAL LIGAMENT AND INTO THE PATIENT¿S BELLY. THE PATIENT THEN HAD TO BE PLACED SUPINE AND AN ANTERIOR APPROACH TO THE SPINE WAS USED TO RETRIEVE THE CAGE. ON 2022-JAN-07, RECEIVED ADDITIONAL INFORMATION THAT, THERE WAS A DELAY IN SURGERY TIME BY ABOUT 75 MINUTES. THIS WAS BECAUSE THE PATIENT HAD TO BE FLIPPED AND THEIR SPINE EXPOSED FROM THE FRONT. ON 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13332652 ↗