XIA 4 5 481322040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327003369), received between Feb 1, 2018 and Feb 3, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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.

• MalfunctionFeb 3, 2018Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE FOLLOW UP, THE ROD HAD SLIPPED OUT OF THE TULIP HEAD OF THE SCREW. THE LOCKING CAP IS STILL IN THE SCREW HEAD, BUT THE ROD IS NO LONGER ENGAGED INTO THE TULIP HEAD. THE PATIENT HAS NOT COME BACK TO THE OR FOR SURGERY. THE SURGEON IS MONITORING THE PATIENT. NO ADVERSE HEALTH CONSEQUENCES HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239838 ↗
• MalfunctionFeb 3, 2018Detachment Of Device Component; Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE FOLLOW UP, THE ROD HAD SLIPPED OUT OF THE TULIP HEAD OF THE SCREW. THE LOCKING CAP IS STILL IN THE SCREW HEAD, BUT THE ROD IS NO LONGER ENGAGED INTO THE TULIP HEAD. THE PATIENT HAS NOT COME BACK TO THE OR FOR SURGERY. THE SURGEON IS MONITORING THE PATIENT. NO ADVERSE HEALTH CONSEQUENCES HAS BEEN REPORTED.

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

  MAUDE report 7239710 ↗
• MalfunctionFeb 1, 2018Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE SURGERY WAS DONE IN (B)(6) 2017, THE PATIENT CAME BACK FOR 3 WEEK FOLLOW UP WITH NO ISSUES AND AT 2 MONTH FOLLOW UP, THE ROD HAD SLIPPED OUT OF THE TULIP HEAD OF THE SCREW. THE LOCKING CAP IS STILL IN THE SCREW HEAD, BUT THE ROD IS NO LONGER ENGAGED INTO THE TULIP HEAD. THE PATIENT HAS NOT COME BACK TO THE OR FOR SURGERY. THE SURGEON IS MONITORING THE PATIENT. NO ADVERSE HEALTH CONSEQUENCES HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234904 ↗