NA 702630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540112934), received between Apr 13, 2018 and Apr 13, 2018 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Break

  AS REPORTED IN MEDWATCH (B)(4): "DURING THE SURGERY, THE EXTRACTOR DRIVER TIP HAD BROKEN INTO THE SCREW [HEAD]. A VERY SMALL PORTION OF THE EXTRACTOR DRIVER TIP THAT CHIPPED OFF (1MM IN LENGTH) WAS NOTED TO BE VISIBLE IN FLUOROSCOPY. THE SURGEON WAS INFORMED AND ATTEMPTED TO EXPLORE THE WOUND TO REMOVE THE OBJECT BUT THE VERY SMALL OBJECT WAS NOT LOCATED". ADDITIONAL INFORMATION RECEIVED FROM THE RISK MANAGER INDICATED THAT THERE WAS REVISION SURGERY DUE TO PAIN WHICH WILL BE REPORTED UNDER STRYKER (B)(4).

  Patient problems: Pain

  MAUDE report 7428347 ↗