N/A 873-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00673978067681), received between Nov 28, 2018 and Apr 23, 2020 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ODONTOID PROCESS FRACTURE; AND UNDERWENT A SURGERY AT C2 USING (B)(6) METHOD. INT RA-OP, IN ORDER TO DETERMINE THE SCREW LENGTH, WHEN AN ATTEMPT WAS MADE TO MEASURE WITH A DEPTH GAUGE, IT WAS NOTICED THAT THE ENGRAVED POSITION OF THE GUIDE WIRE WAS WRONG. THIS REVEALED THAT THE GUIDE WIRE WAS INSERTED IN THE OPPOSITE DIRECTION. THE DIRECTION OF INSERTING GUIDE WIRE WAS WRONG, AND THE BLUNT SIDE WITHOUT THE THREAD WAS INSERTED TO THE VERTEBRA BODY. THE SURGEON MANAGED TO DETERMINE THE SCREW LENGTH WITH THE GUIDE WIRE AS IT WAS AND THE SCREW WAS PLACED. HOWEVER, SCREW INSERTION WAS NOT AT THE POSITION THAT THE SURGEON EXPECTED. MOREOVER, BONE FRAGMENT WAS PUSHED BY WRONG USE OF THE SURGEON, AND THE FRACTURE LINE DEVIATED. ALTHOUGH NO PATIENT COMPLICATIONS WERE REPORTED, THERE IS A POSSIBILITY OF CONSIDERING A RE-OPERATION DUE TO THE IMPERFECTION OF REDUCTION. THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9989521 ↗
• MalfunctionJan 9, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ODONTOID PROCESS FRACTURE; AND UNDERWENT ANTERIOR CERVICAL FIXATION AT C2. INTRA-OP, WHEN THE GUIDE WIRE WAS BEING INSERTED THROUGH THE GUIDE FROM THE ANTERIOR SIDE, THE TIP BROKE AND GOT STUCK INSIDE THE BONE. THE SECOND GUIDE WIRE WAS CONTINUED TO BE INSERTED. THE GUIDE WIRE THAT HAD BEEN STUCK INSIDE THE BONE WAS REMOVED AFTER DRILLING AND THEN SCREW WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO BROKEN FRAGMENTS OF THE GUIDE WIRE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9571254 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ODONTOID PROCESS FRACTURES AND UNDERWENT ANTERIOR SCREW FIXATION SURGERY. DURING SURGERY, THE GUIDE WIRE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109628 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ODONTOID PROCESS FRACTURES AND UNDERWENT ANTERIOR SCREW FIXATION SURGERY. DURING SURGERY, THE GUIDE WIRE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109618 ↗