XIA II 03820650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540148926), received between Feb 24, 2017 and Jan 4, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT: IT IS ABOUT A PATIENT OPERATED SEVERAL TIMES (WE DON'T HAVE THE DETAILS ON THE VARIOUS INTERVENTIONS THIS PATIENT HAD), WHO HAS TODAY A LONG ASSEMBLY OF POSTERIOR FIXATION WITH ILIAC EXTENSION AND INTERSOMATIC CAGES. TO MY KNOWLEDGE, THE PATIENT WAS ASYMPTOMATIC, BUT PROF SPOTTED ON THE X-RAYS, PRESUMABLY DURING A FOLLOW-UP VISIT, THAT THE RIGHT ILIAC SCREW HAD BROKEN. DURING THE REVISION SURGERY, PROF REMOVED THE BROKEN PART OF THE SCREW (TULIP) AND CHANGED THE CONNECTOR ABOVE, BECAUSE HE HAD TO UNSCREW THE BOLTS. THE REST OF THE IMPLANT WAS NOT REMOVED (IMPOSSIBLE) AND PROF PUT A NEW ILIAC SCREW TO MOUNT THE ASSEMBLY AGAIN. THE EVENT WAS OBSERVED PRESUMABLY ON CONTROL IMAGES A FEW MONTHS AFTER IMPLANTATION (IN (B)(6) 2017), THE PATIENT WAS DOING WELL AND PROF WAS SATISFIED WITH THE LEVEL OF FUSION. THE REVISION SURGERY LASTED ABOUT 40 MINUTES WITHOUT X-RAYS.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 7163508 ↗
• InjuryJun 6, 2017Break

  IT WAS REPORTED THAT; THE PATIENT FELT A PAIN IN THE LUMBAR SPINE. DOCTOR FOUND SCREWS HAS BROKEN. THE DOCTOR HAS REMOVED THE BROKEN SCREWS, AND PATIENT CONTINUE TO FOLLOW-UP TREATMENT IN REHABILITATION DEPARTMENT.

  Patient problems: Injury; Pain

  MAUDE report 6616581 ↗
• InjuryFeb 24, 2017Break; Difficult to Remove; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; A LAWSUIT WAS RECEIVED FROM PATIENT, REPORTING THAT THE PATIENT UNDERWENT LUMBAR ARTHRODESIS SURGERY (L2, L3, L4, L5) IN (B)(6) 2011 (CODES NOT REPORTED). HE REPORTS THAT AFTER SURGERY HE BEGAN TO FEEL PAIN AND, ON (B)(6) 2015, HE UNDERWENT AN EXAMINATION WHERE IT WAS FOUND THAT ONE OF THE IMPLANTED SCREWS WAS BROKEN (L5). IN (B)(6) 2015, HE UNDERWENT REVISION SURGERY TO REMOVE THE SCREW, WHICH COULD NOT BE FULLY EXTRACTED (THE TIP OF THE SCREW WAS HOUSED IN THE L5 VERTEBRAL DISC) AND A BONE GRAFT WAS PLACED. PATIENT STILL REPORTS PAIN AND MOBILITY ISSUES.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6358182 ↗