XIA 3 482318590Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540598660), received between Nov 21, 2016 and Sep 8, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676257 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676237 ↗
• InjurySep 8, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676224 ↗
• MalfunctionNov 8, 2019Fracture; Break; Fracture; Detachment of Device or Device Component

  PHYSICIAN REPORTED THAT THE HEAD OF A XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM BROKE OFF INTRA-OPERATIVELY DURING IMPLANTATION. SURGERY WAS SUCCESSFULLY COMPLETED WITH A SMALLER DIAMETER SCREW (7.5X90). THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

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

  MAUDE report 9296355 ↗
• MalfunctionOct 1, 2018Break; Device Slipped; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE NAIL WITH BLOCKER, THE SCREW PULLED OUT. THE RING OF THE INNER PART OF THE SCREW HAD BROKEN WITHOUT LOOSE OF FRAGMENT. THE SURGICAL INCISION WAS WASHED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7924395 ↗
• MalfunctionDec 28, 2016Difficult to Insert; Mechanical Problem; Crack; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT; THE SURGEON OF THE HOSPITAL INFORMED US THAT DURING A SURGERY HE WANTED TO SCREW WITH THE TORQUE WRENCH THE SCREW WITH THE LOCKING SCREW. THE TULIP OF THE SCREW HAS CRACKED AND THE SCREWS COULD NOT BE TURNED TIGHT. THE SCREW WAS REMOVED AND A NEW SCREW WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6209318 ↗
• MalfunctionNov 21, 2016Mechanical Problem; Break; Mechanical Problem; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY. AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE ROD WAS BROKEN(L5-S). THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON TIGHTENED THE BLOCKER USING THE TORQUE WRENCH. WHEN THE SURGEON PULLED OUT THE TORQUE WRENCH, THE SCREW HEAD SEPARATED (L5 RIGHT AND IL LEFT). THEREFORE THE SURGEON CHANGED THE SCREW TO ANOTHER SAME SIZE SCREW.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6118591 ↗