XIA ELEGANCE 482391330LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327276701), received between Apr 26, 2017 and Apr 26, 2017 — 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.

• MalfunctionApr 26, 2017Break; Detachment Of Device Component; Fracture; Difficult to Remove; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DR. PLACED 9.5X50 SCREW IN LEFT S1 PEDICLE DURING REVISION SURGERY. DR WAS REPLACING CURRENT 8.5 DIAMETER SCREW WITH LARGER DUE TO HAVING A 'LOOSE FEEL'. UPON PLACEMENT, DR WANTED TO REMOVE AND REDIRECT DUE TO 'POOR' TRAJECTORY, BUT COULD NOT. DR. BROKE HANDLE/DRIVER/NUT TRYING TO REMOVE WITH PRIMARY DRIVER, THEN SWITCH TO LUMBAR REMOVAL DRIVER OVER A LOCKED DOWN PIECE OF ROD WITH BLOCKER TO TOP OF TULIP TO TRY TO 'HELICOPTER' SCREW OUT SINCE IT WAS SO STUCK. DURING PROCESS OF TRYING TO REMOVE, HE BROKE TULIP/ HEAD OFF OF SCREW OFF OF MAIN SCREW SHAFT. DR COULD NOT REMOVE REMAINDER OF BROKEN SCREW FROM PATIENT WITH LUMBAR REMOVAL SET - SO HE LEFT IT IN PLACE DUE TO NOT HAVING EFFECT PM PATIENT'S OUTCOME AND MOVED ON WITH CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6524012 ↗