Xia 3 System - Serrato 482619590Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327351576), received between Dec 4, 2017 and Jan 19, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 18, 2019Class IITerminated

   Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

   Z-2160-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SCHEDULED REVISION, THE TULIP OF A XIA SERRATO POLYAXIAL SCREW BROKE OFF DURING SCREW REMOVAL. WHILE REPLACING THE SERRATO SCREW, THE TULIP OF A XIA 3 POLYAXIAL SCREW ALSO BROKE OFF. ALL PIECES OF THE FIRST SCREW WERE REMOVED; HOWEVER, THE SHAFT OF THE SECOND SCREW REMAINS IN THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE SERRATO SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194637 ↗
• InjuryJul 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE FINAL TIGHTENING TWO XIA SERRATO POLYAXIAL SCREWS AT S2AI, THE TULIPS SEPARATED FROM THE SHAFTS. ONE OF THE SCREW SHAFTS WAS REMOVED ENTIRELY AND ONE OF THE SCREW SHAFTS REMAINED IN THE PATIENT¿S BONE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF THREE-HOURS AND THE CONSTRUCT WAS COMPLETED WITH THE USE OF ILIAC BOLTS. THIS RECORD REPRESENTS THE SCREW WHOSE SHAFT REMAINS IMPLANTED IN THE PATIENT¿S BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10261167 ↗
• InjuryJul 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE FINAL TIGHTENING TWO XIA SERRATO POLYAXIAL SCREWS AT S2AI, THE TULIPS SEPARATED FROM THE SHAFTS. ONE OF THE SCREW SHAFTS WAS REMOVED ENTIRELY AND ONE OF THE SCREW SHAFTS REMAINED IN THE PATIENT¿S BONE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF THREE-HOURS AND THE CONSTRUCT WAS COMPLETED WITH THE USE OF ILIAC BOLTS. THIS RECORD REPRESENTS THE SCREW WHICH WAS FULLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10261164 ↗
• MalfunctionJul 10, 2019Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  A SCREW LABELLED AS 95 MM, WAS ACTUALLY 100 MM IN LENGTH. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8778453 ↗
• InjuryMar 30, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW WAS BROKEN POST-OPERATIVELY. A REVISION SURGERY WILL BE REQUIRED TO REPLACE THE SCREW.

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

  MAUDE report 8467480 ↗
• MalfunctionDec 4, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE POLY HEAD POPPED OFF OF THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7079544 ↗