XIA 3 482317545Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540562357), received between May 19, 2016 and Aug 11, 2026 — classified as 3 injuries, 6 malfunctions.

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 18, 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203460 ↗
• MalfunctionFeb 20, 2026Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406096 ↗
• MalfunctionMar 4, 2019Break; Detachment of Device or Device Component; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TULIP OF THE XIA DEFENSE SCREW BROKE OFF INTRA-OP WHEN SURGEON WAS IN PROCESS OF FINAL TIGHTENING. A SURGICAL DELAY OF 10 MIN WAS REPORTED. NO OTHER CONSEQUENCE TO THE PATIENT WAS REPORTED.

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

  MAUDE report 8387706 ↗
• MalfunctionJul 18, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE SURGEON WAS REMOVING A SCREW, THE TULIP CAME OFF OF THE SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700459 ↗
• InjuryJul 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT; THE SURGEON, REPORTED THAT THE PATIENT UNDERWENT REVISION OF UNKNOWN SPINE IMPLANTS / SCREW. THE PATIENT PRESENTED WITH ISSUES / POSSIBLY PAIN. THE SURGEON DECIDED TO UNDERTAKE REVISION SURGERY TO REPOSITION A SCREW WHICH WAS EITHER NOT POSITIONED OPTIMALLY OR HAD MOVED FOLLOWING ORIGINAL IMPLANTATION IN 2016. THE PATIENT'S BONE QUALITY WAS DESCRIBED AS POOR. THE SURGEON IS NOT CITING THE IMPLANT AS THE REASON FOR THE REVISION.

  Patient problems: Injury; Pain

  MAUDE report 6713812 ↗
• MalfunctionJul 14, 2017Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT; THE CUSTOMER REPORTED THAT THE PATIENT WAS UNDERGOING REVISION SURGERY AND THAT DURING THE CASE THE TULIP HEAD BECAME DETACHED FROM THE SCREW SHAFT. IT WAS REMOVED IN THE CORRECT WAY USING THE ADJUSTMENT DRIVER WITHOUT EXCESSIVE FORCE. THE SHAFT WAS THEN REMOVED USING THE DRIVER ALSO. THE SURGEON WOULD LIKE TO KNOW WHY THE TULIP HEAD DETACHED DURING EXPLANTATION BECAUSE WHEN THE PATIENT WAS OPENED THE HEAD WAS INTACT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6713754 ↗
• InjuryOct 6, 2016Detachment Of Device Component; Mechanical Problem; Break; Detachment Of Device Component; Mechanical Problem; Device Slipped

  IT WAS REPORTED THAT; THE SCREW TULIP HEAD POPPED OFF OF LEFT L4 SCREW 3 DAYS POST OP. ORIGINAL SURGERY WAS (B)(6). L3-L5 POSTERIOR FUSION. L4 SCREW WAS REMOVED AND NOT REPLACED. THE BROKEN SCREW HAS BEEN SENT TO PATHOLOGY AND WILL BE RELEASED SOMETIME WITHIN THE NEXT 2 WEEKS. AT THAT POINT I WILL SHIP BACK TO STRYKER.

  Patient problems: Injury; No Information

  MAUDE report 6004504 ↗
• InjuryJul 26, 2016Material Separation

  IT WAS REPORTED THAT; ON (B)(6) 2013 PRIMARY SURGERY WAS PERFORMED. THE SCREW HEAD SEPARATION FROM THE SCREW SHAFT WAS FOUND RECENTLY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 5821780 ↗
• MalfunctionMay 19, 2016Detachment Of Device Component; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; THE SALES REP REPORTED THAT THE HEAD OF THE SCREW CAME OFF WHILE THE SURGEON WAS TRYING TO REDUCING A SPONDYLOLISTHESIS (GRADE 2). THE SLIP WAS SIGNIFICANT AND THE SURGEON, WAS TRYING TO REDUCE THIS TO NORMAL SAGITTAL BALANCE. THE SURGEON WAS USING THE CORK SCREW PERSUADER AS PER THE IFU. THERE WAS A SIGNIFICANT SURGICAL DELAY OF APPROXIMATELY 45 MINUTES BECAUSE THE SCREW AND ROD NEEDED TO BE REPLACED. UPDATE: THE CUSTOMER FURTHER REPORTED THAT THE CASE WAS AN L5/S1 CORRECTION FOR A GRADE 2 SPONDYLOLISTHESIS WITH POSTERIOR DECOMPRESSION AND EXPANDIBLE CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5666465 ↗