EXPEDIUM 179912650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034086484), received between May 4, 2022 and May 4, 2022 — 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.

• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEAD ON THE SCREW DEVICE BROKE OFF. ACCORDING TO THE REPORT, THE SURGEON WAS ATTEMPTING TO DRIVE THE SCREW DEEPER IN THE PEDICLE, AND IN THE PROCESS, THE SCREW HEAD BROKE OFF, LEAVING JUST THE SCREW SHANK IN THE PEDICLE OF THE PATIENT. THIS WAS AT THE LEVEL OF L5 ON THE LEFT SIDE OF THE PATIENT. IT WAS REPORTED THAT THE SURGEON HAD TO MAKE NUMEROUS ATTEMPTS TO REMOVE THE BROKEN SCREW AND WAS ULTIMATELY ABLE TO DO SO VIA HOSPITAL PROVIDED INSTRUMENTATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272818 ↗