Medtronic Reusable Instrument 875777Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CATALYST 875777 C DISTRACTER/INSERTER · Class 2
All models of Medtronic Reusable Instrument (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885074464701), received between Dec 9, 2024 and Mar 2, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break5
- Crack1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT. IT WAS REPORTED THAT, IT MADE A SOUND WHEN THE SURGEON GRASPED TIGHTLY DURING CAGE INSERTION THEN THE INSERTER WAS DAMAGED. THE PROCEDURE PERFORMED WAS ANTERIOR CERVICAL FUSION. THE INSERTER BROKE WHEN THE CAGE WAS BEING INSERTED. 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 24479785 ↗MalfunctionDec 31, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL DISC HERNIATION. IT WAS REPORTED THAT THE HANDLE BROKE WHEN THE OPERATOR GRIPPED IT DURING CAGE INSERTION. 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 23932259 ↗MalfunctionNov 10, 2025Crack; Crack
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL SPINE ANTERIOR FUSION SPINAL THERAPY FOR CERVICAL SPONDYLOTIC MYELOPATHY. LEVELS IMPLANTED AT C4/5. IT WAS REPORTED THAT THE HANDLE HAD CRACKS DURING POST-OPERATIVE CLEANING AND STERILIZATION. 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 23507758 ↗MalfunctionOct 28, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) THERAPY AT C3/4/5 FOR CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE CATALYST INSERTER HANDLE BROKE DURING INSERTION, CAUSING A DELAY OF LESS THAN 60 MINUTES. 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 23401549 ↗MalfunctionAug 28, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. 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 22910501 ↗MalfunctionJan 3, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4/5 CERVICAL S PINE ANTERIOR DECOMPRESSION AND FIXATION DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT CATALYST WAS USED WHEN INSTALLING THE ANATOMIC PTC. ONE SIDE OF THE HANDLE BROKE WHEN GRIPPED THE HANDLE UNTIL IT WAS FINALLY INSTALLED. PERHAPS BECAUSE THE VERTEBRAE WERE NARROW, WHEN IT WAS TRIED TO PULL OUT THE CATALYST AFTER INSERTING THE CAGE, IT CAME OUT WITH THE CAGE ONCE, SO THE DOCTOR DECIDED THAT HE COULDN'T HOLD IT ALL THE WAY TO THE END, SO HE SET IT AGAIN, INSERTED IT, AND WHEN HE GRIPPED IT, IT BROKE. 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 21065170 ↗MalfunctionDec 9, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT, THE WHEN THE CAGE WAS PLACED IN THE INTERVERTEBRAL DISC SPACE USING THE CATALYST INSERTER, THE INSERTER HANDLE WAS DAMAGED. THE LEVELS TREATED WERE C4/6. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20876773 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page