Medtronic Reusable InstrumentRecalls & reported problems across all models

We found 3 models of Medtronic Reusable Instrument by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2021 and Mar 2, 2026 — classified as 3 deaths, 6 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (44 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Medtronic Reusable Instrument problems

Medtronic Reusable Instrument models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Medtronic Reusable Instrument 6550202

  DISPENSER, CEMENT
  2 deaths59 reports
• Medtronic Reusable Instrument 875777

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  7 reports
• Medtronic Reusable Instrument 6550102

  DISPENSER, CEMENT
  1 death1 report

Recent Medtronic Reusable Instrument adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 1, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION (L4) DUE TO SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER CEMENT INJECTION, THE GUIDE TIP REMAINED WHEN THE DELIVERY DEVICE WAS REMOVED. THEY TRIED TO REMOVE IT BY REATTACHING THE KOCHER AND DELIVERY GUIDE, BUT EXTRACTION WAS NOT POSSIBLE. DUE TO THE PPS INCISION, DIRECT INSPECTION NEAR THE SCREW HEAD REVEALED CEMENT HEAD LEAKAGE. NO LEAKAGE WAS OBSERVED IN THE CROWN AREA. A LUMP OF CEMENT WAS FOUND AROUND THE POSITION OF THE SCREW HEAD AND TAB (ACCORDING TO THE PHYSICIAN¿S INITIAL OBSERVATION). THE CEMENT WAS BROKEN WITH A MALLET AND CHISEL, AND THE GUIDE TIP WAS SUCCESSFULLY REMOVED. IT WAS CONFIRMED THAT NO CEMENT REMAINED AROUND THE SCREW OR CROWN, AND THE OPERATION WAS COMPLETED WITH FINAL LOCKING. 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 23677903 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1-S1 LUMBAR POSTERIOR ANCHORING THERAPY FOR MYELOPATHY. IT WAS REPORTED THAT AFTER INSTALLING THE CEMENT DELIVERY GUIDE, IT WAS CONFIRMED THAT IT WAS PROPERLY INSTALLED; HOWEVER, IT WAS CONFIRMED THAT THE CEMENT LEAKED FROM THE SCREW HEAD. THERE WAS NO MALFUNCTION ASSOCIATED WITH CEMENT DELIVERY GUIDE, BONE FILLER DEVICE AND SCREW. 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 23520191 ↗
• 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 30, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS L2 COMPRESSION FRACTURE. IT WAS REPORTED THAT, FENESTRATED SCREW WAS PLACED FROM L1 TO L3, AND CEMENT WAS INJECTED. RETENTION OF THE TIP WAS OBSERVED ONLY ON THE RIGHT SIDE OF L1. FOR APPROXIMATELY 5 MINUTES, APPROPRIATE MEASURES WERE TAKEN, AND EXTRACTION WAS PERFORMED USING A KOCHER FORCEPS. LEVELS IMPLANTED WERE L2 BALLOON KYPHOPLASTY AT L1-3. THERE WERE NO ABNORMALITIES ASSOCIATED WITH REPORTED CEMENT. THERE WAS DELAY OF LESS THAN 60MINUTES REPORTED AS A RESULT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422429 ↗
• 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 ↗
• MalfunctionSep 19, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A REGULAR VOYAGER SURGERY, CEMENT LEAKAGE OCCURRED FROM THE FNS TIP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO CEMENT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093313 ↗
• MalfunctionSep 4, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TH11-L5 CEMENT INJECTION INTO 2A2B PORTION OF THE AFFECTED VERTEBRA WITH 3A3B FIXATION DUE TO L2 COMPRESSION FRACTURE. IT WAS REPORTED THAT WHILE INJECTING CEMENT INTO THE LEFT SIDE OF L1, CEMENT FILLING WAS INITIATED BEFORE THE OUTER SHEATH OF THE CEMENT DELIVERY DEVICE WAS PROPERLY FITTED INTO THE CEMENT DELIVERY GUIDE. AS A RESULT, CEMENT LEAKED FROM THE SIDE OF THE CEMENT DELIVERY GUIDE. NO ABNORMALITIES WITH THE CEMENT ITSELF HAVE BEEN REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 22961526 ↗
• 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 ↗
• MalfunctionAug 27, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A FNS TIP USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A LEAK DURING INJECTING THE CEMENT WITH SCREWS WHILE USING THE FNS TIP DURING A FIXATION SPINE-CEMENTED SCREWS IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902204 ↗
• MalfunctionAug 27, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED THAT PRE-OP FOR THE PATIENT WAS COMPRESSION FRACTURE AND OSTEOPOROSIS. 12 PEDICLE SCREWS WAS USED TO STABILIZE THE LUMBAR SEGMENT FROM L1 TO S1. FOLLOWING CEMENT DELIVERY AND REMOVAL OF THE DELIVERY GUIDE, CEMENT LEAKAGE OBSERVED AT ALL 12 SCREW SITES. THE CEMENT EXTRAVASATED ONTO THE SCREW HEADS, CAUSING THE DELIVERY TIPS TO ADHERE TO THE SCREW HEADS. ADDITIONALLY, AN INSUFFICIENT AMOUNT OF CEMENT WAS DELIVERED INTO THE PEDICLES, WHICH RESULTED IN THE TEAM SPENDING OVER AN HOUR CAREFULLY REMOVING THE LEAKED CEMENT AND DETACHING THE DELIVERY TIPS. THE PATIENT'S CONDITION HAD REMAINED STABLE WITH NO COMPLICATIONS REPORTED. THE DOCTOR DECIDED TO EXTEND THE PATIENT'S STAY IN HOSPITAL FOR MORE INVESTIGATIONS AND ASSESSMENT; A CT SCAN HAD BEEN DONE TO MAKE SURE THAT EVERYTHING WAS DONE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902197 ↗
• MalfunctionAug 27, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A FNS TIP USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A LEAK DURING INJECTING THE CEMENT WITH SCREWS WHILE USING THE FNS TIP DURING A FIXATION SPINE-CEMENTED SCREWS IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902188 ↗
• MalfunctionAug 27, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A FNS TIP USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A LEAK DURING INJECTING THE CEMENT WITH SCREWS WHILE USING THE FNS TIP DURING A FIXATION SPINE-CEMENTED SCREWS IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902185 ↗
• MalfunctionAug 27, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A FNS TIP USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A LEAK DURING INJECTING THE CEMENT WITH SCREWS WHILE USING THE FNS TIP DURING A FIXATION SPINE-CEMENTED SCREWS IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902172 ↗

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