NA U44-640-14-02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705034711031), received between Feb 4, 2020 and Feb 4, 2020 — classified as 1 injury.

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 18, 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.

• InjuryFeb 4, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ANTERIOR CERVICAL FUSION, A DISTRACTOR PIN BROKE OFF IN C5. FRAGMENTS WERE GENERATED AND THE FRAGMENT REMAINED IN THE PATIENT'S C5 VERTEBRAL BODY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE (1) DISTRACTOR PINS-STERILE 14MM LENGTH THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9664869 ↗