Medtronic Reusable Instrument 6550202Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 20763000211039), received between Jun 9, 2021 and Dec 1, 2025 — classified as 2 deaths, 6 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (43 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 22902167 ↗
• 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 22902158 ↗
• 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 22902150 ↗
• 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 22902137 ↗
• 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 22902130 ↗
• 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 22902078 ↗
• 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 22902054 ↗
• MalfunctionAug 26, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3 & L5 PERCUTANEOUS PEDICLE SCREWS SPINAL THERAPY FOR 1A1B FUSION AND L4 VERTEBRAL BODY REPLACEMENT FOR L4 RUPTURED FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS INJECTED INTO THE FM OF L5, BUT IT LEAKED FROM THE SCREW HEAD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS ARE RELATED TO THE CEMENT LEAK FROM THE SCREW HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892238 ↗
• InjuryAug 25, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBRAL BODY FORMATION/TRANSCUTANEOUS POSTERIOR FUSION FOR OSTEOPOROTIC VERTEBRAL FRACTURE. IT WAS REPORTED THAT DURING CEMENT FILLING OF THE CEMENT SCREW; CEMENT LEAKED TO THE SCREW HEAD. BECAUSE CEMENT LEAKED TO THE SCREW HEAD, THE CEMENT DELIVERY GUIDE TIP WAS RETAINED. THE PLANNED PERCUTANEOUS SURGERY ENDED UP NOT BEING ENTIRELY PERCUTANEOUS, RESULTING IN A SIGNIFICANTLY LARGER INCISION BEING MADE. THERE WAS A DELAY OF GREATER THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. A TOTAL OF 8 SCREWS WERE USED IN THE FIXED RANGE TH11/L3. ONLY THE RIGHT SIDE OF L2 LEAKED CEMENT ON THE SCREW HEAD SIDE. THE GUIDE TIP COULD BE REMOVED, BUT AFTER INSERTING THE ROD, THE SET SCREW COULD NOT BE INSERTED ON THE RIGHT SIDE OF L2. FOR THE RIGHT SIDE OF L2, THE SET SCREW INSTALLATION WAS ABANDONED. 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 22881852 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POLYPHENYLENE SULFIDE FUSION SPINAL THERAPY FOR L2 VERTEBRAL FRACTURE. LEVELS IMPLANTED WERE T11/L5. IT WAS REPORTED THAT CEMENT LEAKAGE WAS OBSERVED FROM THE GAP BETWEEN THE T12 LEFT PEDICLE SCREW (PS) AND THE DEFECTIVE FNS TIP. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATES THAT THE CEMENT HAS NO ISSUES, AS NO PROBLEMS WERE OBSERVED WHEN IT WAS USED WITH OTHER SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628558 ↗
• MalfunctionJul 25, 2025Leak/Splash; Failure to Align; Leak/Splash; Failure to Align

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY AT TH12 FOR THORACIC VERTEBRAL FRACTURE. IT WAS REPORTED THAT CEMENT WAS FILLED AFTER SCREW INSERTION. PARTIAL LEAKAGE TO THE SCREW HEAD DURING CEMENT FILLING. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER INSERTING THE SCREW, A DELIVERY GUIDE WITH A TIP WAS ATTACHED, AND FILLED 1CC OF CEMENT WITH THE DELIVERY DEVICE. AFTER 3 MINUTES, WHEN THE DELIVERY GUIDE WAS REMOVED, PART OF THE CEMENT WAS ATTACHED TO THE SCREW HEAD AND THE TIP OF THE TIP. IT WAS NOT A LEAK THAT COULD BE CONFIRMED IN THE IMAGE. GUIDE WIRE HAS ALSO PASSED, THE AXIS WAS CAPTURED, THE GREEN LINE OF THE DELIVERY GUIDE WAS BELOW THE BLACK LINE OF THE EXTENDER, AND THERE WAS NO PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MALFUNCTION WITH THE CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607541 ↗
• MalfunctionJul 21, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TH11-L3 POSTERIOR FIXATION (PERCUTANEOUS) FOR L1 OSTEOPOROTIC VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE GUIDE TIP ON THE LEFT SIDE OF L2 COULD NOT BE REMOVED. WHILE STRUGGLING, IT WAS EXTRACTED USING A KOCHER CLAMP, DURING WHICH A SMALL AMOUNT OF CEMENT LEAKED INTO THE HEAD. 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 22553179 ↗
• MalfunctionJun 23, 2025Material Fragmentation; Leak/Splash; Material Fragmentation; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T11-L3 PROCEDURE FOR THE FIRST LUMBAR VERTEBRAL COMPRESSION FRACTURE FIXATED FROM THE 11TH THORACIC VERTEBRA TO THE 3RD LUMBAR VERTEBRA. IT WAS REPORTED THAT AFTER FILLING THE SCREW WITH CEMENT, A CHIP REMAINED ON THE 11TH THORACIC SCREW. AFTER REMOVAL, A SMALL AMOUNT OF LEAKAGE WAS FOUND AT THE SCREW HEAD. CEMENT LEAKED FROM THE FNS TIP. ALL FNS CHIPS WERE REMOVED. 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 22305808 ↗
• MalfunctionJun 20, 2025Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294674 ↗
• MalfunctionJun 12, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5/ POSTERIOR LUMBAR INTERBODY FUSION (PLIF) THERAPY FOR LUMBAR CANAL STENOSIS (LCS) AT L4/5/S. IT WAS REPORTED THAT AFTER INSERTING THE SCREWS AT EACH LEVEL, THE AXIS WAS CHECKED WITH A 1.5 K-WIRE, AND CEMENT WAS FILLED. HOWEVER, CEMENT LEAKED FROM THE FITTING AREA BETWEEN THE TIP AND SCREW HEAD ON BOTH SIDES OF S1. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS REPORTED AND THERE WERE NO PARTICULAR PROBLEMS WITH THE BONE FILLER DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192529 ↗