N/A 5484855Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994609809), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXATION FOR SCOLIOSIS. IT WAS REPORTED THAT THE PEDICLE FRACTURED WHEN THE TAP WAS USED, SO THE SCREW WAS NOT INSERTED INTO THE FRACTURED PEDICLE. IT OCCURRED IN 2 PLACES, BUT THE SITE IS UNKNOWN. THE TWO SCREWS REPORTED WERE ATTACHED TO THE SCREWDRIVER, BUT THEY WERE NOT INSIDE THE PATIENT'S BODY. PUNCTURE WAS MADE WITH A PROBE AND THE PEDICLE WAS CUT OUT AFTER TAPPING. THE SCREW WAS SKIPPED WITHOUT BEING INSERTED. THE PRODUCTS WERE EXPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 18071699 ↗