XIA 3 482318570Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540598646), received between May 25, 2016 and Aug 11, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Detachment of Device or Device Component

  A company representative reported that the tulip of a Xia 3 Polyaxial Screw disengaged intra-operatively. The procedure was completed successfully with a 20 minute surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203473 ↗
• InjuryApr 17, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 1.5 YEARS POST-OPERATIVELY TO ADDRESS A LEFT-SIDED XIA POLYAXIAL SCREW FRACTURE AND A RIGHT-SIDED XIA POLYAXIAL SCREW MIGRATION. THE PATIENT REPORTED EXPERIENCING MECHANICAL LOW-BACK PAIN. THIS REPORT IS FOR THE XIA POLYAXIAL SCREW THAT FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16750887 ↗
• InjurySep 1, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND IMAGING REVEALED A FRACTURED XIA II LP POLYAXIAL SCREW, A FRACTURED XIA II ROD, AND A XIA 3 TITANIUM POLYAXIAL SCREW WITH "HEAD PULL OUT." THE PATIENT UNDERWENT REVISION SURGERY. THE BODY OF THE XIA 3 TITANIUM POLYAXIAL SCREW WAS NOT ABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE PATIENT'S ILIUM. THIS REPORT CAPTURES THE XIA 3 TITANIUM POLYAXIAL SCREW.

  Patient problems: Pain

  MAUDE report 12407821 ↗
• MalfunctionNov 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHEN FINAL TIGHTENING THE XIA 3 ILIAC POLY SCREW, 8X5 X 70MM, THE HEAD POPPED OFF THE SCREW. THE SCREW WAS REMOVED AND REPLACED WITH A 9.5 X 70MM SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE DELAY AND THE PATIENT WAS UNHARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372081 ↗
• MalfunctionFeb 25, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW WAS BROKEN POST-OPERATIVELY. THE PATIENT IS CURRENTLY UNDER OBSERVATION AND NO SURGERY HAS BEEN PLANNED YET. NO ADVERSE CONSEQUENCE TO PATIENT WAS REPORTED.

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

  MAUDE report 8366830 ↗
• MalfunctionFeb 25, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT AFTER FINAL TIGHTENING DURING IMPLANT SURGERY, THE SURGEON FELT THAT THE BLOCKER WAS INSIDE THE HEAD OF THE SCREW DEEPER THAN USUAL. AT ONE WEEK AFTER OPERATION, THE SCREW WAS NOTED TO BE DISENGAGED AT THE BASE OF THE SCREW HEAD. THE PATIENT IS CURRENTLY UNDER OBSERVATION AND NO SURGERY HAS BEEN PLANNED YET. NO ADVERSE CONSEQUENCE TO PATIENT WAS REPORTED. .

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

  MAUDE report 8366826 ↗
• MalfunctionSep 26, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER INSERTION OF THE RIGHT SIDE NAIL WITH BLOCKER, SCREW PULL OUT WAS CONFIRMED IN IMAGE EXAMINATION. THE SCREW HAS BEEN REMOVED AND REPLACED. WHEN THE LEFT SIDE NAIL AND SCREW WERE PLACED, IT ALSO PULLED OUT DURING COMPRESSION; THE SCREW WAS REMOVED AND REPLACED BY ANOTHER, WHICH HAD THE HEAD LOCKED. THE DOCTOR REMOVED THE SCREW AND CHOSE NOT TO PUT ANOTHER. IT WAS FURTHER REPORTED THAT ONE OF THE SCREWS DID PULL OUT OF THE HEAD AND AFTER PULLOUT VERIFIED, IT WAS NOTICED THAT THE RING ON THE INSIDE OF THE SCREW HAD BROKEN WITHOUT LARGE LOOSE FRAGMENTS. THE SURGICAL INCISION WAS WASHED. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910838 ↗
• MalfunctionNov 14, 2016Mechanical Problem; Disassembly; Mechanical Problem

  IT WAS REPORTED THAT; SURGEON REVIEWED XRAYS OF A PREVIOUS PATIENT WHO UNDERWENT A FUSION ON (B)(6) 2016. HE NOTED THAT THE HEAD OF THE LEFT ILIAC BOLT SCREW HAS DISENGAGED FROM THE SCREW SHAFT WHICH IS STILL IN THE PATIENT. SURGEON USES AN OSTEOTOME TO CREATE A HOLE IN THE ILIAC WING AND THEN UNDER FLUOROSCOPY PROCEEDS TO USE A LENKE PROBE TO CREATE A PATH FOR THE SCREW. HE THEN USES A PEDICLE FEELER, A HEMOSTAT & A RULER TO CHOSE THE SCREW LENGTH. HE DOES NOT TAP FOR ILIAC BOLTS. AFTER PUTTING PELVIC BOLTS IN BILATERALLY HE DOES BIRDS-EYE VIEWS OF EACH BOLT TO ENSURE THEY ARE IN THE WING. HE THEN CONNECTS OFFSET NEUTRAL SHORT CONNECTORS WITH BLOCKERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100728 ↗
• InjuryMay 25, 2016Material Separation; Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT; PELVIC SCREW WAS USED ON A L2 TO THE PELVIS REVISION SURGERY ON (B)(6) 2016. DOCTOR CALLED ME AND SAID THE HEAD HAS SEPARATED FROM THE SCREW.

  Patient problems: Injury; No Code Available

  MAUDE report 5680635 ↗