XIA II 48047033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327263312), received between Aug 3, 2017 and Aug 3, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT;THE REGIONAL SALES MANAGER SPINE REPORTED THE FOLLOWING EVENT : " DURING A PROCEDURE RELATED TO AN EXTRACTION OF 8 SCREWS ON A (B)(6) PATIENT, THE NEUROSURGEON THOUGHT HE COULD PERFORM THE SURGERY WITH THE ABLATION KIT MADE BY THE SALES REP IN 2016 (THE KIT WAS DELIVERED IN (B)(6) 2016). DR FIRST TRIED THE SCREWDRIVER IN THE BOX (FIRST GENERATION ) AND THEN OPENING THE BUT TO NO AVAIL. THE ONLY ANCILLARY DEVICE THAT REMOVES THE SCREWS CORRECTLY IS THE INTERNAL SCREWDRIVER ROD , WHICH WAS NOT PLACED IN THE ABLATION KIT. DR SUCCEEDED IN REMOVING 2 SCREWS WITH GOUGE FORCEPS BUT THE SURGEON DECIDED TO STOP THE SURGERY BECAUSE IT WAS TOO COMPLICATED AND RISKY FOR THE PATIENT (ACCORDING TO THE OR MANGER AT THE HOSPITAL WHO PHONED ). SO DR DID NOT COMPLETE THE SURGERY SUCCESSFULLY AND PLANNED TO REVISE THE PATIENT NEXT WEEK (TUESDAY (B)(6)). ASKED TO FRANCE TO HAVE AN ABLATION KIT SENT URGENTLY TO MAKE SURE THAT THE REMOVAL OF THE LAST 6 SCREWS WILL BE REMOVED SERENELY DURING THE NEXT SURGERY."

  Patient problems: Injury; No Code Available

  MAUDE report 6763169 ↗