NA 03.804.520SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034722672), received between Mar 15, 2024 and Mar 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PRODUCT BROKE OFF IN THE PATIENT LEAVING METAL IN THE PATIENT¿S L5 PEDICLE. THE PATIENT IS RECOVERING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT 10 GAUGE-BEVEL TIP SIDE-OPENING-STERILE. THIS IS REPORT 4 OF 6 FOR (B)(4) .

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913167 ↗
• MalfunctionMar 15, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PRODUCT BROKE OFF IN THE PATIENT LEAVING METAL IN THE PATIENT¿S L5 PEDICLE. THE PATIENT IS RECOVERING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT 10 GAUGE-BEVEL TIP SIDE-OPENING-STERILE. THIS IS REPORT 3 OF 6 FOR (B)(4) .

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913164 ↗
• MalfunctionMar 15, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PRODUCT BROKE OFF IN THE PATIENT LEAVING METAL IN THE PATIENT¿S L5 PEDICLE. THE PATIENT IS RECOVERING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT 10 GAUGE-BEVEL TIP SIDE-OPENING-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4) .

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913159 ↗