Catalyft PL Expandable Interbody System 6061002Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000253554), received between Aug 14, 2024 and Mar 6, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K210425); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE DRIVER FROM THE CATALYFT INSTRUMENT SET WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528964 ↗
• MalfunctionJan 21, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT THE SURGEON WANTED TO ATTEMPT TO EXPAND THE CAGE BEYOND THE TORQUE LIMIT AND ATTACHED A NON-TORQUE LIMITED T-HANDLE TO THE DRIVER AND CONTINUED TO TURN THE DRIVER UNTIL THE TIP SHEERED OFF. THE TIP OF THE EXPANSION DRIVER WAS LODGED IN THE FEMALE HEX DRIVE OF THE CAGE IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24128105 ↗
• MalfunctionMar 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER SNAPPED OFF WHILE TORQUING THE DRIVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639996 ↗
• MalfunctionFeb 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT PRODUCT BROKE IN SPD. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431982 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR 3-5 SPONDY AND STENOSIS. IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE FOR LUMBAR 3-5 SPONDYLOLISTHESIS AND STENOSIS, SEVERAL ISSUES OCCURRED WITH THE SURGICAL INSTRUMENTS. THE TIP OF THE CATALYFT DRIVER BROKE WHILE EXPANDING THE IMPLANT, AND ALTHOUGH THE TIP WAS RETRIEVED, IT WAS DISCARDED ON THE FIELD AND NOT RECOVERED. ADDITIONALLY, THE NAV TAP COLD WELDED INTO ONE OF THE NAV LOCKS, AND IT WAS DISCOVERED THAT THE TAP ITSELF WAS BENT, ALTHOUGH OTHER INSTRUMENTS WERE ABLE TO BE USED WITH THE NAV LOCK WITHOUT ISSUES. THE TRIM LINE BLADES WERE ALSO DAMAGED, SHOWING SEVERAL MARKINGS AND SCRUFFS FROM HIGH-SPEED BURRS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352935 ↗
• MalfunctionJan 30, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING L3-4 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT THE TORQUE OF DRIVER REACHED ITS LIMIT AND THE TIP OF THE DRIVER WAS ALSO SHEARED OFF. THERE WAS MANUFACTURING ISSUE ASSOCIATED WITH THE REPORTED DRIVER AND NO ABNORMALITIES OBSERVED ON HANDLES. 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 21271990 ↗
• MalfunctionJan 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER SHAFT WAS SHEARED OFF. THERE WAS NO PATIENT INVOLVED IN THE EVENT. IT WAS REPORTED THAT THE REPORTED DRIVER WAS USED ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263625 ↗
• MalfunctionJan 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING INSERTER DRIVERS. IT WAS REPORTED THAT THE INNER SHAFT WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE RE PORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249212 ↗
• MalfunctionJan 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF DRIVER WAS BROKEN DURING SET ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228755 ↗
• MalfunctionJan 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING PLIF FOR KYPHOSIS. IT WAS REPORTED THAT THE DRIVER BROKE, AND BROKEN FRAGMENTS REMAINS INSIDE THE PATIENT. THERE WAS NO PLAN FOR REVISION SURGERY. NO HEALTH IMPACT ON PATIENT DUE TO THIS EVENT. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED BECAUSE OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21075982 ↗
• MalfunctionDec 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING 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. 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. ADDITIONAL INFORMATION RECEIVED STATES, 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033376 ↗
• MalfunctionNov 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 TRANSFORAM INAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT WHILE PREPARING THE L4/5 DISC SPACE FOR INSERTION OF THE CATALYFT TLIF IMPLANT, IT WAS DETERMINED THAT THE DISC SPACE WAS COLLAPSED AND EXTRAORDINARILY HARD BONE WAS PRESENT. ONE SIZE 7MM LONG PL IMPLANT WAS SELECTED BY TRIALING AND INSERTER INTO THE DISC SPACE. WHEN ATTEMPTING TO EXPAND THE IMPLANT, GREAT FORCE WAS ENCOUNTERED AND MUCH RESISTANCE TO THE EXPANSION WAS FELT BY THE SURGEON, RESULTING IN THE TIP OF THE EXPANSION DRIVER BREAKING OFF IN THE IMPLANT. THE SURGEON DETERMINED THAT ENOUGH EXPANSION HAD BEEN ACHIEVED AND THE BROKEN DRIVER TIP WAS REMOVED FROM THE IMPLANT AND PATIENT. THE PATIENT WAS NOT HARMED AND AND NO DELAY TO THE CASE CAUSED BY THE ISSUE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SHAVER HAS SIGNIFICANT SCORING ON THE SHAFT WHERE THE INSTRUMENT CONNECTS TO THE NAVLOCK TRACKER. THE SCORING PREVENTED THE TWO INSTRUMENTS FROM C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804288 ↗
• MalfunctionSep 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS BROKEN OFF SO WHEN THE SURGEON WENT TO EXPAND THE CAGE, THE DRIVER WAS JUST SPINNING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332335 ↗
• MalfunctionAug 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY FOR PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT THE TIP OF THE INSERTER SHEARED OFF AND OF THE INNER SLEEVE OF THE DRIVER SHEERED OFF IN THE SCREW. INSERTER TIP COLD-WELDED IN THE CAGE AND THEREFORE REMAINED THERE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19979247 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210425. One submission often covers many models, so check the product and lot details in each record.

• Z-0580-2026 · Sep 16, 2025 · Open, Classified
  Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068