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Catalyft PL Expandable Interbody System 6068076Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 6068076 CATALYFT PL LONG 7MM · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This is a Medtronic Catalyft PL expandable cage used in lumbar spine fusion surgery to hold the vertebrae apart. Most of the 46 reports describe the cage losing its height or collapsing after implantation, or shifting out of position, sometimes needing a second operation. There are no deaths and 11 injuries. One open recall, started in September 2025, says the cage may lose height and that surgical technique and instructions were being updated.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
46
Deaths reported
0
Injuries reported
11
Recalls naming it
1

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00763000246709), received between Sep 9, 2022 and Aug 17, 2026 — classified as 11 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (32 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 8 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 5 reportsSep 2024: 0 reportsOct 2024: 11 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202611
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Mechanical Problem32
  • Migration12
  • Migration or Expulsion of Device5
  • Mechanics Altered3
  • Adverse Event Without Identified Device or Use Problem1
  • Expulsion1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • No Clinical Signs, Symptoms or Conditions37
  • Pain3
  • Numbness2
  • Back pain1
  • Cerebrospinal Fluid Leakage1
  • Hemorrhage/Blood Loss/Bleeding1
  • Muscle Weakness/Atrophy1
  • Neuropathy1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 17, 2026Migration

    Information was received from clinical study, healthcare provider (HCP) via a manufacturer representative regarding a patient having Spinal therapy. It was reported that, at the Unscheduled 01 visit, Hardware Condition was adjudicated by MMI Imaging as one or more components of the fixation hardware has moved from its original location. There was only one cage was implanted and there was progressive dorsal displacement of intervertebral cage (L3-L4). There were no patient symptoms reported. No further complications reported regarding the event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50271056 ↗
  • InjuryMay 21, 2026Expulsion

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

    Patient problems: Muscle Weakness/Atrophy; Numbness; Urinary Retention

    MAUDE report 25240042 ↗
  • InjuryNov 18, 2025Migration; Migration

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT SUBJECT COMPLETED STUDY X-RAYS ON (B)(6) 2025 <(>&<)> (B)(6) 2025. PI NOTED POSTOPERATIVE FINDINGS. THERE IS FURTHER DORSAL DISPLACEMENT OF THE INTERVERTEBRAL CAGE AT L3-L4, 11 MM VS 6.4 MM VS PRIOR 5.6 MM. HE IS ORDERING A LUMBAR CT TO EVALUATE FUSION. ONSET DATE: 2025-10-22 EVENT: DISPLACEMENT OF AN INTERVERTEBRAL CAGE IMPLANT AT THE LUMBAR SPINE LEVELS L3¿L4. SEVERITY: MODERATE HOSPITALIZATION: THE ADVERSE EVENT RESULTED IN HOSPITALIZATION. OTHER ACTIONS TAKEN: LUMBAR CT SCAN WILL BE ORDERED. TREATMENT: NO ADDITIONAL TREATMENT WAS PROVIDED DUE TO THE EVENT AT THIS TIME. OUTCOME STATUS: PATIENT IS RECOVERING OR RESOLVING. DIAGNOSTICS: NO DIAGNOSTIC TESTS HAVE BEEN PERFORMED YET, BUT A CT SCAN IS PLANNED. SITE SERIOUSNESS ASSESSMENT: NO CONGENITAL ANOMALY, DEATH, DISABILITY, LIFE-THREATENING EVENT, OR MEDICAL INTERVENTION REPORTED. SITE RELATED ASSESSMENT: USE OF TLIF GRAFTING MATERIAL UNLIKELY RELATED TO THE EVENT. PROCEDURE (POSTOPERATIVE) UNLIKELY RELATED TO THE EVENT. COMMENTS: THE ADVERSE EVENT INVOLV

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

    MAUDE report 23578774 ↗
  • MalfunctionOct 21, 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 LOST LORDOSIS AFTER IMPLANTATION WITHIN 2 MONTHS. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. NO ADDITIONAL/REVISION SURGERY PERFORMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23345079 ↗
  • MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE IN L3/4 AND L4/5 MIS TLIF (MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT THE L3/4 CAGE PARTIALLY COLLAPSED. THERE WAS NO REVISION SURGERY REPORTED AS A RESULT OF THE EVENT. 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 22529271 ↗
  • 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 AND L4/5 MIS TLIF (MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT THE L3/4 CAGE PARTIALLY 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 22274982 ↗
  • MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED DURING A CLINICAL TLIF STUDY PROCEDURE. IT WAS REPORTED THAT THE 7MM LONG CATALYFT CAGE WAS LOADED ONTO THE INSERTER, LOADED IT WITH AUTOLOGOUS BONE GRAFT. IMAGE GUIDANCE WAS UTILIZED TO INSERT IMPLANT INTO DESIRED LOCATION IN L4/5 DISC SPACE. THE CAGE EXPANDED, THE HANDLE WAS MAKING SCREECHING SOUND LIKE IT WAS ABOUT TO TORQUE LIMIT, BUT WOULD THEN SLIP. IT WAS TRIED SEVERAL TIMES TO GET THE DEFINITIVE CLICK SOUND OF THE TORQUE LIMITING HANDLE. IT WAS REALIZED THAT A STEP HAD BEEN MISSED IN FOLLOWING THE TLIF STUDY PROTOCOL, AND INFUSE HAD NOT YET BEEN PLACED IN THE INTERSPACE. THE EXPANSION DRIVER WAS USED TO LOWER THE IMPLANT HEIGHT AND A SLAP HAMMER WAS USED TO EXPLANT THE CAGE. DURING RE-IMPLANTATION IT WAS DISCOVERED THAT THE DEVICE WOULDN'T EXPAND AT ALL. SO ANOTHER 7MM CAGE WAS OPENED, WHICH WORKED FINE AND TORQUE LIMITED WITH EASE. 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 21583419 ↗
  • MalfunctionMar 11, 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 HAS LOST DISTRACTION HEIGHT FROM 12.8 TO 12MM IMPLANTED AT THE LEVEL L4/L5. PATIENT HAD POST OPERATIVE BACK PAIN. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Back pain

    MAUDE report 21570893 ↗
  • InjuryJan 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REGARDING A PATIENT HAVING L2-3 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR AN INDICATION OF STENOSIS. IT WAS REPORTED THAT THE CATALYFT PL CAGE BACKED OUT POSTERIORLY. SIX MONTHS POST-OPERATIVELY, COMPUTED TOMOGRAPHY REVEALED THE CAGE HAD BACKED OUT, CAUSING RADICULOPATHY SYMPTOMS. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO DRIVE THE CAGE FURTHER IN AND MEDIALIZED ITS DIRECTION. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY. THERE WERE NO FURTHER COMPLAICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Neuropathy

    MAUDE report 21132926 ↗
  • MalfunctionJan 2, 2025Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM PATIENT AND HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF SPINAL THERAPY FOR LUMBAR VERTEBRA DEGENERATION. IT WAS REPORTED THAT CAGE JACK DOWN. 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 21052887 ↗
  • MalfunctionDec 28, 2024Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED IN MIS-TLIF THERAPY FOR LCS. LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT THERE WERE NO PROBLEMS AFTER THE SURGERY, AND THERE WERE NO PROBLEMS WITH THE PHOTOS TAKEN AT THE TIME OF DISCHARGE ON (B)(6). ON (B)(6), WHEN AN X-RAY WAS TAKEN DURING A 1-MONTH POSTOPERATIVE PERIODIC MEDICAL CHECK-UP, IT WAS DISCOVERED THAT THE CY CAGE THAT WAS JACKED UP WAS JACKED DOWN. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE JACKED UP CY CAGE HAS LOWERED. ADDITIONAL INFORMATION WAS RECEIVED. NO ADDITIONAL SURGERY WAS PLANNED AS A RESULT OF THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21031457 ↗
  • MalfunctionNov 19, 2024Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR DEGENERATIVE SCOLIOSIS AT T9/ILIAC. IT WAS REPORTED THAT THERE WAS DEVICE CONTRACTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE CAGE WAS NOT MIGRATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20720981 ↗
  • MalfunctionOct 25, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA REGULATORY BODY REGARDING A PATIENT HAVING DECOMPRESSION. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE INCLUDING COLLAPSE AND EXTRUSION. 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 20531405 ↗
  • MalfunctionOct 25, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A USER REPORT REGARDING A PATIENT HAVING DECOMPRESSION. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE IN SEVERAL PATIENTS INCLUDING COLLAPSE AND EXTRUSION. THERE WAS NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20530518 ↗
  • MalfunctionOct 24, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA REGULATORY BODY REGARDING A PATIENT HAVING DECOMPRESSION. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE INCLUDING COLLAPSE AND EXTRUSION. 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 20522738 ↗
  • MalfunctionOct 24, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE, REGULATORY BODY REGARDING A PATIENT IMPL ANTED WITH SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE INCLUDING COLLAPSE AND EXTRUSION. 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 20522238 ↗
  • MalfunctionOct 24, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A USER REPORT REGARDING A PATIENT HAVING DECOMPRESSION. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE IN SEVERAL PATIENTS INCLUDING COLLAPSE AND EXTRUSION. 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 20522175 ↗
  • MalfunctionOct 24, 2024Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A USER REPORT REGARDING A PATIENT HAVING DECOMPRESSION. IT WAS REPORTED THAT THERE WAS FAILURE OF DEVICE IN SEVERAL PATIENTS INCLUDING COLLAPSE AND EXTRUSION. 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 20520922 ↗
  • MalfunctionOct 24, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA REGULATORY BODY REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, FAILURE OF DEVICE IN SEVERAL PATIENTS INCLUDING COLLAPSE AND EXTRUSION. PROCEDURE/TECHNIQUE PERFORMED WAS DECOMPRESSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20520751 ↗
  • MalfunctionOct 23, 2024Mechanics Altered; Mechanics Altered

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/3 TLIF DISC DISSECTION AND INSTRUMENTATION. THE PATIENT HAD MEDICAL HISTORY OF DIABETES. IT WAS REPORTED THAT AFTER INSERTING THE CAGE, AN ATTEMPT WAS MADE TO EXPAND THE CAGE WITH THE INSERTER DRIVER, BUT THE SCREWDRIVER COULD NOT BE PROPERLY ENGAGED AND COULD NOT EXPAND. THE PHYSICIAN DECIDED NOT TO RE-INSERT THE CAGE AND LEAVE AS IT IS BECAUSE THE PATIENT HAD ALOT OF BLEEDING. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 20512507 ↗
  • MalfunctionOct 22, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

    INFORMATION WAS RECEIVED FROM THE REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DEVICE COLLAPSE AND EXTRUDED. NO OTHER PATIENT INJURY / COMPLICATION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20507424 ↗
  • MalfunctionOct 15, 2024Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS RADICULOPATHY, MYELOPATHY. IT WAS REPORTEDTHAT THE CAGE COULD NOT BE EXPANDED. 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 20448864 ↗
  • MalfunctionOct 14, 2024Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING PLIF POSTER IOR LUMBAR INTERBODY FUSION THERAPY FOR SEPARATION SLIPPAGE. LEVEL AT WHICH IMPLANT PERFORMED WAS L4/5. IT WAS REPORTED THAT AFTER INSERTION OF THE CAGE, AN ATTEMPT WAS MADE TO EXPAND, HOWEVER, THE EXPAND FAILED. THE GRAFT AUGER WAS USED, BUT IT DID NOT CHANGE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT IT HAPPENED DURING NORMAL USE OF THE DEVICE DURING SURGERY AND NOT AN INITIAL FAILURE. THE INSERTED IMPLANT WAS CHECKED IN THE SURGICAL FIELD, BUT THE GRAFTED BONE WAS STUCK IN THE CAGE, AND THE SCREWDRIVER DID NOT FIT AND COULD NOT BE OPENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20438055 ↗
  • MalfunctionAug 21, 2024Mechanics Altered; Mechanics Altered

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 3-S1 DECOMPRESSION FUSION PROCEDURE. IT WAS REPORTED THAT ONE OF THE CAGES IN THE PATIENT COLLAPSED/FAILED. NO PLAN TO EXPLANT THE 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 20013699 ↗
  • MalfunctionAug 21, 2024Mechanics Altered; Mechanics Altered

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 3-S1 DECOMPRESSION FUSION PROCEDURE. IT WAS REPORTED THAT ONE OF THE CAGES IN THE PATIENT COLLAPSED/FAILED. NO PLAN TO EXPLANT THE 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 20013310 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.