XIA 3 48232600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540560582), received between Feb 16, 2016 and Jan 10, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT A XIA 3 TITANIUM ROD FRACTURED POST-OPERATIVELY. ONE 600MM XIA 3 TITANIUM ROD WAS CUT AND IMPLANTED BILATERALLY. THE PATIENT HAD EXPERIENCED EXTERNAL TRAUMA (PATIENT FELL). SUBSEQUENTLY, WHEN THE PATIENT CAME IN FOR A POST-OPERATIVE EXAMINATION, IT WAS NOTED THAT THE ROD FRACTURED BILATERALLY AS WELL AS THE VERTEBRAL BODY. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED ROD AND ADD ADDITIONAL FIXATION. THIS RECORD CAPTURES THE LEFT SIDE FRACTURE OF THE XIA TITANIUM ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13213040 ↗
• InjuryNov 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT A XIA 3 TITANIUM ROD FRACTURED POST-OPERATIVELY. ONE 600MM XIA 3 TITANIUM ROD WAS CUT AND BOTH PIECES WERE IMPLANTED BILATERALLY. THE PATIENT HAD EXPERIENCED AN EXTERNAL TRAUMA (PATIENT FELL). SUBSEQUENTLY, WHEN THE PATIENT CAME IN FOR A POST-OPERATIVE EXAMINATION IT WAS NOTED THAT THE ROD FRACTURED BILATERALLY AS WELL AS THE VERTEBRAL BODY. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED ROD AND ADD ADDITIONAL FIXATION. THIS RECORD CAPTURES THE RIGHT SIDE FRACTURE OF THE XIA TITANIUM ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740822 ↗
• InjuryJun 1, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2014 PATIENT WAS IMPLANTED FROM T10 TO ILIAC AND 4 RODS WERE DEPLOYED FROM T10 TO L4 AND 2 RODS WERE DEPLOYED AFTER L5. AFTER THE OPERATION, THE 2 RODS WERE BROKEN UNDER L4. ON (B)(6) 2018 A REVISION SURGERY WAS PERFORMED AND THE BROKEN RODS WERE REMOVED AND 4 RODS WERE IMPLANTED. LOOSE S1 SCREWS WERE EXCHANGED WITH NEW 1MM THICK SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 7560739 ↗
• InjuryJun 1, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2014 PATIENT WAS IMPLANTED FROM T10 TO ILIAC AND 4 RODS WERE DEPLOYED FROM T10 TO L4 AND 2 RODS WERE DEPLOYED AFTER L5. AFTER THE OPERATION, THE 2 RODS WERE BROKEN UNDER L4. ON (B)(6) 2018 A REVISION SURGERY WAS PERFORMED AND THE BROKEN RODS WERE REMOVED AND 4 RODS WERE IMPLANTED. LOOSE S1 SCREWS WERE EXCHANGED WITH NEW 1MM THICK SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 7560671 ↗
• InjuryJun 1, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS FIXED FROM AROUND T10 TO THE ILIAC BONE. POST OPERATIVELY, TWO RODS BROKE ON BOTH SIDES NEAR THE ILIAC SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN RODS. ADDITIONAL ACTIONS PERFORMED DURING REVISION: LOOSEN THE SCREW OF S1 AND REPLACE TO 1MM THICK SCREW AND FIX IT TO THE CAUDAL SIDE OF THE ILIAC CONNECTOR WITH 4 RODS.

  Patient problems: Injury; No Code Available

  MAUDE report 7560532 ↗
• InjuryJun 1, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS FIXED FROM AROUND T10 TO THE ILIAC BONE. POST OPERATIVELY, TWO RODS BROKE ON BOTH SIDES NEAR THE ILIAC SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN RODS. ADDITIONAL ACTIONS PERFORMED DURING REVISION: LOOSEN THE SCREW OF S1 AND REPLACE TO 1MM THICK SCREW AND FIX IT TO THE CAUDAL SIDE OF THE ILIAC CONNECTOR WITH 4 RODS.

  Patient problems: Injury; No Code Available

  MAUDE report 7560531 ↗
• InjuryMay 23, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED FROM T8 TO ILIAC AND FIXED FROM T10 TO L3/4 WITH 4 RODS ON (B)(6) 2014. ON (B)(6) 2018 IT WAS CONFIRMED BOTH SIDE RODS WERE BROKEN. RIGHT BROKEN PART WAS L5/S AND LEFT BROKEN PART WAS SECRU / ILIAC. ON (B)(6) 2018 RODS WERE REMOVED AND REVISED.

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

  MAUDE report 7537708 ↗
• InjuryMay 8, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 AND DEVICES WERE IMPLANTED FROM T4 TO ILIAC. POST OPERATIVELY IT WAS DISCOVERED THAT THE ROD BROKE AT THE HEAD SIDE OF T12. REVISION SURGERY TOOK PLACE ON (B)(6) 2018. THE SCREW WAS DEPLOYED FROM T7 TO T11 AND THE ROD WAS CUT AT THE CAUDAL SIDE OF THE OF THE T12 AND THE SCREW OF THE T12 WAS REMOVED. FINALLY, IT WAS EXTENDED WITH CONNECTOR AND THE OPERATION WAS FINISHED.

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

  MAUDE report 7493406 ↗
• InjuryMay 8, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 AND DEVICES WERE IMPLANTED FROM T4 TO ILIAC. POST OPERATIVELY IT WAS DISCOVERED THAT THE ROD BROKE AT THE HEAD SIDE OF T12. REVISION SURGERY TOOK PLACE ON (B)(6) 2018. THE SCREW WAS DEPLOYED FROM T7 TO T11 AND THE ROD WAS CUT AT THE CAUDAL SIDE OF THE OF THE T12 AND THE SCREW OF THE T12 WAS REMOVED. FINALLY, IT WAS EXTENDED WITH CONNECTOR AND THE OPERATION WAS FINISHED.

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

  MAUDE report 7493403 ↗
• InjuryFeb 16, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT PRIMARY SURGERY WITH SPINAL FIXATION RODS. AFTER SURGERY, WHEN THE PATIENT TRIED TO CARRY A HEAVY BAGGAGE, ROD IN ONE SIDE BROKE. ANOTHER DAY, WHEN THE PATIENT BENT FORWARD, THE ROD IN ONE SIDE BROKE. THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016.

  Patient problems: Injury; No Code Available

  MAUDE report 5439406 ↗