EXPEDIUM 179912899Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034086958), received between May 14, 2019 and May 14, 2019 — 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.

• InjuryMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD T9-PELVIS POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2016. DURING A ROUTINE CLINIC FOLLOW UP VISIT ON (B)(6) 2019, IT WAS FOUND THAT PATIENT HAD BROKEN RODS (PART 1799-63-450) AT L3 AND A FRACTURED SCREW (PART 1799-12-899) AT THE RIGHT ILIUM. LIKELY CAUSE WAS NON-UNION AT L2-3. X-RAY AND CT SCANS WERE DONE TO CONFIRM. REVISION SURGERY OCCURRED ON (B)(6) 2019. BROKEN HARDWARE WAS REMOVED AND REVISED TO CORRECT THE NON-UNION. THE IMPLANTS WERE DISCARDED BY THE HOSPITAL AND ARE NOT AVAILABLE TO SHIP TO DEPUY FOR EVALUATION. THE LOT NUMBER OF THESE ITEMS IS NOT KNOWN. BOTH SURGERIES OCCURRED AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 8609325 ↗