NA 03.804.517SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034722641), received between Feb 18, 2020 and Mar 15, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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-DIAMOND TIP/END-OPENING-STERILE. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913170 ↗
• 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-DIAMOND TIP/END-OPENING-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4) .

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913168 ↗
• 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-DIAMOND TIP/END-OPENING-STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18913165 ↗
• MalfunctionNov 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT SUSTAINED A T8 COMPRESSION FRACTURE LAST YEAR THAT WAS TREATED CONSERVATIVELY. SHE HAS HAD PERSISTENT PAIN SINCE THEN. IMAGING REVEALED ABNORMAL SIGNAL AND DEFORMITY WITHIN THE ANTERIOR T8 VERTEBRAL BODY AND WAS LOCALIZED WITH FLUOROSCOPY. SINGLE SHOT VIEWS REVEALED A LYTIC LESION WITH A SCLEROTIC MARGIN IN THE ANTERIOR ASPECT OF THE VERTEBRAL BODY. THE ENTRY POINTS FOR THE BILATERAL PEDICLES WERE MARKED WITH A SKIN MARKER, AND SMALL STAB INCISIONS WERE CREATED AT THE MARKED SITES THE T8 VERTEBRAL BODY WAS THEN ACCESSED VIA THE LEFT PEDICLE UTILIZING A 15G DEPUY SYSTEM TROCAR WITH THE TROCAR TIP PLACED INTO THE LEFT ANTERIOR ASPECT OF THE BODY. NEEDLE TIP POSITIONED WAS VERIFIED WITH MULTIPLE FLUOROSCOPIC VIEWS. A SPINE BIOPSY WAS ATTEMPTED THROUGH THE TROCAR BUT SUFFICIENT TISSUE COULD NOT BE OBTAINED. THEREFORE, A SECOND 10G TROCAR WAS PLACED THROUGH THE RIGHT PEDICLE IN AND DIRECTED TOWARDS THE POSTERIOR SCLEROTIC EDGE OF THE LESION IN THE VERTEBRAL BODY. AN 11G BIOPSY NEEDLE WAS THEN INSERTED THROUGH THE RIGHT TROCAR , AND A CORE BIOPSY WAS OBTAINED. AFTER THE END OF THE PROCEDURE, THIS MATERIAL WAS SENT FOR PATHOLOGIC ANALYSIS AND

  Patient problems: Pain

  MAUDE report 12882100 ↗
• InjuryJun 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A VERTEBROPLASTY PROCEDURE, WHILE USING THE CONFIDENCE NEEDLES WITH A PATIENT WHO HAS VERY HARD BONE MAKING IT DIFFICULT TO INSERT THE NEEDLE, A LARGER DIAMOND ACCESS KIT 10 GAUGE WAS USED. TOWARDS THE END OF THE PROCEDURE DURING THE REMOVAL OF THE CONFIDENCE NEEDLE (ON THE LEFT SIDE), IT BECAME DIFFICULT TO REMOVE AND THE HANDLE BROKE OFF. THE DIAMOND NEEDLE ON THE RIGHT SIDE HAD ALREADY BEEN REMOVED AND THEY WERE WORKING ON THE LEFT WITH THE CANNULA ON THE RIGHT SIDE WITH THE BROKEN HANDLE. THE NEEDLE REMAINED IN THE VERTEBRAL BODY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11995591 ↗
• MalfunctionFeb 19, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE THE SURGEON PERFORMED A BALLOON VERTEBROPLASTY ON A PATIENT WITH A L5 PATHOLOGIC FRACTURE. THE TWO (2) ACCESS KIT HANDLES WERE BROKEN. WHILE PLACING THE ACCESS KIT NEEDLE AND TROCHAR VIA A TRANSPEDICULAR APPROACH, IT WAS FOUND OUT THAT THE PATIENT HAD VERY HARD BONE. HE HAD TO MALLET ON THE TOP OF THE BLUE TROCHAR PART OF THE ACCESS KIT AGRESSIVELY. AFTER HE HAD THE TROCHAR AND WORKING SLEEVE IN THE POSITION HE WANTED, HE TRIED TO REMOVE THE TROCHAR PORTION AND IT WAS STUCK. HE TWISTED THE BLUE HANDLE PART AND KEPT TRYING TO REMOVE IT, BUT IT WAS ANCHORED INTO THE PATIENTS L5 BONE. AFTER CONTINUING TO TRY AND REMOVE IT, THE BLUE HANDLE CAME OFF OF THE TROCHAR SHAFT. HE TRIED REMOVED THE SHAFT WITH PLIERS AND OTHER FORCEPS, BUT WAS UNSUCCESSFUL. HE ENDED UP REMOVING THE WORKING SLEEVE ALONG WITH THE TROCHAR. THIS EXACT THING HAPPENED ON BOTH THE LEFT AND RIGHT SIDES. AFTER REMOVING BOTH ACCESS KITS WITH THE BROKEN TROCHAR HANDLES, HE PLACED 2 NEW ACCESS KITS WHICH THE NURSE OPENED UP. NO FRAGMENTS REMAINED IN PATIENT. THERE WAS A FIFTEEN (15) MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9726872 ↗
• MalfunctionFeb 18, 2020Component Misassembled; Component Misassembled

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720287 ↗