XIA 3 48233480Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613154918454), received between Jul 13, 2018 and Dec 3, 2018 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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.

• MalfunctionDec 3, 2018Migration; Device Slipped; Migration

  SURGEON REPORTED THAT MULTIPLE RODS SLIPPED OUT OF CLOSED HEAD ILIAC SCREWS AT PATIENT FOLLOW UP. REVISION SURGERY HAS NOT OCCURRED. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 8124072 ↗
• MalfunctionDec 3, 2018Migration; Device Slipped; Migration

  SURGEON REPORTED THAT MULTIPLE RODS SLIPPED OUT OF CLOSED HEAD ILIAC SCREWS AT PATIENT FOLLOW UP. REVISION SURGERY HAS NOT OCCURRED. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 8124038 ↗
• MalfunctionNov 30, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT TWO RODS DISLODGED POST OP. DISLODGING. THE PRODUCTS ARE STILL IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAS BEEN REPORTED.

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

  MAUDE report 8119046 ↗
• MalfunctionNov 30, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT TWO RODS DISLODGED POST OP. THE PRODUCTS ARE STILL IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAS BEEN REPORTED.

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

  MAUDE report 8119023 ↗
• MalfunctionNov 29, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE TWO RODS HAVE DISLODGED POST-OP. THE PRODUCTS STILL IMPLANTED IN THE PATIENT. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

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

  MAUDE report 8114496 ↗
• MalfunctionNov 29, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE TWO RODS HAVE DISLODGED POST-OP. THE PRODUCTS STILL IMPLANTED IN THE PATIENT. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

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

  MAUDE report 8114495 ↗
• InjuryJul 13, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO THE BREAKING OF TWO RODS INITIALLY IMPLANTED IN 2006 IN A SCOLIOSIS - LONG FIXATION SURGERY. THE PHYSICIAN REPORTED THE RODS BROKE WITHOUT CAUSING TRAUMA TO THE PATIENT. THE RODS WERE REVISED. THE FIRST ROD WAS KEPT ENTIRELY AND RECOMPOSED BY A CONNECTOR. THE SECOND ROD WAS REMOVED AND REPLACED BY A STUMP.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7687575 ↗
• InjuryJul 13, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO THE BREAKING OF TWO RODS INITIALLY IMPLANTED IN 2006 IN A SCOLIOSIS - LONG FIXATION SURGERY. THE PHYSICIAN REPORTED THE RODS BROKE WITHOUT CAUSING TRAUMA TO THE PATIENT. THE RODS WERE REVISED. THE FIRST ROD WAS KEPT ENTIRELY AND RECOMPOSED BY A CONNECTOR. THE SECOND ROD WAS REMOVED AND REPLACED BY A STUMP.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7687573 ↗