Xia 3 System - Serrato 48268011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327356656), received between Jul 13, 2018 and Oct 2, 2018 — classified as 4 malfunctions.

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

• MalfunctionOct 2, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INNER ROD OF THE SCREWDRIVER BROKE. REPLACEMENT WAS AVAILABLE. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 7926989 ↗
• MalfunctionAug 28, 2018Break; Fracture; Material Twisted/Bent; Fracture

  SURGEON WAS PLACING A 6.5X40MM SCREW INTO THE L5 PEDICLE AND THE SCREWDRIVER WAS BENDING AT AN EXTREME ANGLE. IT SNAPPED IN HALF BEFORE THE SCREW WAS PLACED INTO ITS FINAL POSITION. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825292 ↗
• MalfunctionJul 17, 2018Break; Fracture; Material Split, Cut or Torn; Fracture

  IT WAS REPORTED THAT A SCREWDRIVER BROKE IN HALF WHILE INSERTING A SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694463 ↗
• MalfunctionJul 13, 2018Break; Fracture; Component Missing; Fracture

  IT WAS REPORTED THAT DURING REMOVAL OF A POLYAXIAL SCREW, THE SHANK END OF THE SCREWDRIVER BROKE AT THE TIP. THE BROKEN PART WAS LOST BECAUSE OF THE SURGICAL ASPIRATOR. REPLACEMENT INSTRUMENT WAS AVAILABLE. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687497 ↗