NA 207.736Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982148483), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2018Crack; Crack

  IT WAS REPORTED THAT ON AN (B)(6) 2018, THE PATIENT UNDERWENT AN IMPLANTATION PROCEDURE AND WAS INITIALLY IMPLANTED WITH A CANNULATED SCREW, THE THREAD CAME OFF AND WAS THOUGHT TO BE ENCASED IN THE BONE. IT WAS DETERMINED AFTER THE FOLLOW-UP THAT THE SCREW NEEDS TO BE TAKEN OUT. ALL OF THE METAL SCREW WAS REMOVED WITHOUT ISSUE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/36MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8056834 ↗