N/A 698343320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034497853), received between Mar 14, 2020 and Mar 14, 2020 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 14, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE WHICH STATED OF A BROKEN STRIPPED SCREWDRIVER. THE SURGEON WAS KNOWN FOR 7-10 MINUTES FOR REMOVING THE BROKEN DISTAL TIP OUT OF THE RIA IMPLANT SYSTEM USING EXPEDIUM 5.5 IMPLANT, TAKING THE IMPLANT SCREWS. THERE WAS A SURGICAL DELAY OF APPROXIMATELY SEVEN TO TEN (7-10) MINUTES. THERE WERE FRAGMENTS GENERATED AND EASILY REMOVED. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: EXPEDIUM 5.5 SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9832822 ↗