XIA 3 48236043Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540560872), received between Mar 21, 2016 and Dec 8, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED XIA 3 TITANIUM MULTIAXIAL CROSSLINK THE DAY AFTER IMPLANTATION. THE PATIENT REPORTED, "NUMBNESS OF THE LEFT LEG," AND THE PHYSICIAN REPORTED A HEMATOMA HAD FORMED.

  Patient problems: Hematoma; Numbness

  MAUDE report 18296948 ↗
• MalfunctionDec 10, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE PATIENT WAS IMPLANTED WITH A XIA CONSTRUCT ON (B)(6) 2017. ON (B)(6) 2018, IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED AND THE RIGHT SIDE XIA II ROD FRACTURED AFTER THE PATIENT EXPERIENCED A FALL. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD BEEN REVISED ON (B)(6) 2021 TO ADDRESS THE PREVIOUSLY REPORTED DISENGAGED SCREW AND FRACTURED ROD, AS WELL AS A SECOND ROD FRACTURE (ON THE LEFT SIDE). DURING REVISION SURGERY, A XIA 3 POLYAXIAL SCREW WAS NOTED TO BE LOOSE AND TWO XIA 3 MULTIAXIAL CROSSLINKS WERE REMOVED. EVALUATION OF THE RETURNED DEVICES IDENTIFIED THAT BOTH CROSSLINKS WERE FRACTURED. THIS RECORD CAPTURES THE SECOND OF TWO XIA 3 MULTIAXIAL CROSSLINKS REMOVED DURING THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977789 ↗
• MalfunctionOct 30, 2017Mechanical Problem; Component Missing; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE OR MANAGER AT THE HOSPITAL REPORTED THAT: " THE DEVICE COULD NOT BE IMPLANTED AS A SCREW WAS MISSING". ON 10/30/2017 UPDATE: RESPONSES RECEIVED FROM THE CUSTOMER WHO REPLIED THAT: " THE PROCEDURE ENDED WELL EVEN IF THE SURGEON HAD TO FIND A SOLUTION AND IMPLANTED ANOTHER IMPLANT WHICH WAS LESS SUITED FOR THE PATIENT ( ANOTHER SIZE WAS PROPOSED AND IMPLANTED) NO MEDICAL INTERVENTION, NO SURGICAL DELAY, ADVERSE CONSEQUENCES FOR THE PATIENT AS THE IMPLANT IS NOT THE ONE PLANNED AT THE BEGINNING OF THE SURGERY.

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

  MAUDE report 6989372 ↗
• MalfunctionOct 17, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, THE CENTER SCREW OF THE CROSSLINK BROKE WHEN THE SURGEON FASTEN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6954347 ↗
• MalfunctionJun 30, 2017Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT; AFTER FINAL FIXATION, WHEN THE MULTIAXIAL CROSSLINK WAS DEPLOYED AND THE CENTER NUT WAS LOOSED, THE INNER SCREW WAS BROKEN. THEREFORE, THE MULTIAXIAL CROSSLINK WAS CHANGED THE NEW SAME ONE AND THE OPERATION WAS SUCCEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681469 ↗
• MalfunctionFeb 6, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; ATTEMPTED TO CONNECT AND ROD BY THE NUT DRIVER, THE MIDDLE OF SCREW WAS BROKEN. REPLACED ANOTHER SCREW AND IMPLANTED. COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6305928 ↗
• MalfunctionMay 25, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; ON (B)(6) 2014, (TH10-S2AI) SURGERY WAS PERFORMED. AFTER THAT, THE BREAKAGE OF THE BOTH SIDE ROD AT UNDER L4 WAS FOUND. THE MAC WAS ALSO BROKEN AT L5/S1 AND THE SCREW WAS ALSO BROKEN AT LEFT SAI. SO THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, AT L4/5 WAS DONE. THE SPINAL DEFORMITY OF THE PATIENT WAS TERRIBLE.

  Patient problems: Injury; No Code Available

  MAUDE report 5680356 ↗
• MalfunctionMar 21, 2016Disassembly; Mechanical Problem; Disassembly; Loose or Intermittent Connection; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON WAS USING A MULTI-AXIAL CROSS CONNECTOR DURING A L5/S1 FIXATION CASE. WHILE USING THE HEX DRIVER TO ADVANCE THE SCREW, ONE OF THE SET SCREWS CAME LOOSE AND DETACHED FROM THE CROSS CONNECTOR. THE SURGEON WAS UNABLE TO REATTACH THE SCREW AND USED A DIFFERENT MULTI-AXIAL CROSS CONNECTOR TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514511 ↗