n/a 6550041Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000216740), received between Nov 13, 2023 and Nov 10, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509855 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509837 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509825 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509800 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509667 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509480 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509408 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509363 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509310 ↗
• MalfunctionNov 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUIDE SLEEVES HELD THE CEMENT DELIVERY TIPS VERY LOOSELY AND WHEN CEMENT WAS APPLIED CEMENT CAME OUT OF THE TULIPS OF THE GUIDES THAT DID NOT HAVE A TIGHT FIT TO THE TIPS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509236 ↗
• MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TH12 WAS STABILIZED USING A 22-FENESTRATED SYSTEM SPINAL THERAPY FOR VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHILE THE DELIVERY GUIDE WAS ATTACHED TO THE SCREW, AN ATTEMPT WAS MADE TO SET THE OUTER SHEATH OF THE DELIVERY DEVICE ONTO THE GUIDE. HOWEVER, THE CLAWS OF THE OUTER SHEATH FAILED TO REACH THE NECK OF THE DELIVERY GUIDE, PREVENTING PROPER ATTACHMENT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALTHOUGH THE GREEN LINE OF THE GUIDES EXCEEDED THE BLACK LINE OF THE SCREW TAB, THE DOCTOR SAID THAT THERE WAS NO FEELING THAT THE AXES WERE ALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711533 ↗
• MalfunctionAug 20, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A FNS TIP AND CEMENT DELIVERY GU IDE USED ON PATIENT HAVING LAMINECTOMY THERAPY, STABILIZATION WITH VOYAGER 5.5 IMPLANTS FOR D12 FRACTURE ON OSTEOPOROTIC PATIENT. IT WAS REPORTED THAT THE CEMENT LEAKED BETWEEN TIPS AND SCREWS. THE SURGEON WAS FORCED TO REMOVED A SCREW BECAUSE A TIP WAS IMPOSSIBLE TO REMOVE FROM THE TULIP. GUIDE DIDN'T SECURELY HOLD THE TIP AND OFTEN THE TIP REMAINED ENGAGED IN THE SCREW TULIP. SO IT MADE IMPOSSIBLE TO COMPLETE BONE AUGMENTATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS A DELAY OF 1 HOUR IN OVERALL PROCEDURE. THE PROCEDURE WAS PARTIALLY COMPLETED, IT WAS IMPOSSIBLE TO INJECT CEMENT DURING BONE AUGMENTATION. LEVEL IMPLANTED D10 ¿ D11¿ L1 ¿ L2. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006886 ↗
• MalfunctionNov 13, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DORSAL STABILIS ATION, FENESTRATED FROM L3 TO L5 FOR AN INDICATION OF L4 OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT AFTER CEMENTING, THE FNS TIP REMAINED STUCK IN THE TULIP DESPITE IMMEDIATE REMOVAL FROM THE SCREW HEAD. 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 18127929 ↗
• MalfunctionNov 13, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DORSAL STABILIZATION, FENESTRATED FROM L3 TO L5 FOR AN INDICATION OF L4 OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT AFTER CEMENTING, THE FNS TIP REMAINED STUCK IN THE TULIP DESPITE IMMEDIATE REMOVAL FROM THE SCREW HEAD. 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 18127924 ↗
• MalfunctionNov 13, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DORSAL STABILIS ATION, FENESTRATED FROM L3 TO L5 FOR AN INDICATION OF L4 OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT AFTER CEMENTING, THE FNS TIP REMAINED STUCK IN THE TULIP DESPITE IMMEDIATE REMOVAL FROM THE SCREW HEAD. 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 18127919 ↗
• MalfunctionNov 13, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DORSAL STABILIS ATION, FENESTRATED FROM L3 TO L5 FOR AN INDICATION OF L4 OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT AFTER CEMENTING, THE FNS TIP REMAINED STUCK IN THE TULIP DESPITE IMMEDIATE REMOVAL FROM THE SCREW HEAD. 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 18127918 ↗