N/A 7967088Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994551962), received between May 13, 2020 and Jan 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVER TIP BROKE AND ISN¿T RETAINING A SCREW VERY WELL. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053040 ↗
• InjuryMay 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION 51 DUE TO PSEUDOARTHROSIS AT L5-S1 AND BACK PAIN. REMOVAL OF THE BRANTIGAN CAGE (FROM ANOTHER MANUFACTURER) WAS PERFORMED. INTRA-OP, AFTER INSERTING THE SCREWS IN THE CAGE USING THE REPORTED DRIVER, WHEN THE DRIVER WAS BEING REMOVED, IT WAS DIFFICULT TO BE REMOVED AS ITS TIP GOT STUCK IN THE SCREW HOLE. WHEN SURGEON PULLED THE DRIVER TO REMOVE IT, THE DRIVER CAME IN CONTACT WITH THE BLADE OF THE RETRACTOR WITH A BOUNCE. AS A RESULT OF THIS, THE VEIN (THAT HAD BEEN PROTECTED BY THE RETRACTOR) HAD AN EMPTY PINHOLE OF ABOUT 1.5 MM AND THE BLEEDING OCCURRED. THE SURGEON TRIED ASTRICTION WITH THE HEMOSTATIC AGENT (TACHOCOMB). THE SURGEON ASKED FOR ASSISTANCE FROM A VASCULAR SURGERY PHYSICIAN IN THE HOSPITAL TO SEEK ADVICE WHEN THE BLEEDING HAD SUBSIDED TO SOME EXTENT. THE VASCULAR SURGERY PHYSICIAN CONFIRMED THE BLEEDING POINT AND DETERMINED THAT THERE WAS NO PROBLEM AS IT WAS, SO THE OPERATION WAS CONTINUED. AFTER THE HEMOSTATIC TREATMENT, THE WOUND CLOSURE WAS PERFORMED, AND POSTERIOR FIXATION WAS CONTINUED TO BE PERFORMED AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PRO

  Patient problems: Blood Loss; Injury

  MAUDE report 10052454 ↗