Xia 3 System - Serrato 482616545Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327352658), received between Nov 7, 2018 and Nov 27, 2024 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  IT WAS REPORTED THAT THE IDEAL SIZED XIA SERRATO POLYAXIAL SCREW WAS NOT AVAILABLE INTRA-OPERATIVELY, AND THAT SMALLER SIZED XIA SERRATO POLYAXIAL SCREWS WERE IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO XIA SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791525 ↗
• MalfunctionNov 27, 2024Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  IT WAS REPORTED THAT THE IDEAL SIZED XIA SERRATO POLYAXIAL SCREW WAS NOT AVAILABLE INTRA-OPERATIVELY, AND THAT SMALLER SIZED XIA SERRATO POLYAXIAL SCREWS WERE IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO XIA SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790009 ↗
• MalfunctionOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SERRATO POLYAXIAL SCREW FRACTURE. REVISION SURGERY HAS NOT BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 17970077 ↗
• InjuryOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS A SERRATO POLYAXIAL SCREW FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 17970012 ↗
• MalfunctionOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SERRATO POLYAXIAL SCREW FRACTURE. REVISION SURGERY HAS NOT BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 17969788 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.

  Patient problems: Pain

  MAUDE report 16258395 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.

  Patient problems: Pain

  MAUDE report 16258376 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.

  Patient problems: Pain

  MAUDE report 16258289 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.

  Patient problems: Pain

  MAUDE report 16258244 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIA SERRATO SCREW BROKE THE PEDICLE UPON IMPLANTATION INTO L2 INTRA-OPERATIVELY. NO DEVICE SPECIFIC ISSUES WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311060 ↗
• InjuryFeb 4, 2021Migration; Migration

  A PHYSICIAN REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A LOOSE XIA SERRATO POLYAXIAL SCREW PLACED AT S1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279618 ↗
• InjuryJan 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A SERRATO POLYAXIAL SCREW LOOSENED POST OPERATIVELY. PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11150003 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  A PHYSICIAN REPORTED THAT A SERRATO POLYAXIAL SCREW, "BROKE OUT OF PEDICLE WHEN FINAL TIGHTENING." THE SURGERY WAS COMPLETED SUCCESSFULLY FOLLOWING A 30-MINUTE DELAY IN WHICH THE CONSTRUCT WAS EXTENDED BY ONE LEVEL TO ACCOMMODATE SKIPPING THE LEVEL WITH THE BROKEN PEDICLE.

  Patient problems: Vertebral Fracture

  MAUDE report 10610072 ↗
• MalfunctionAug 27, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT A SERRATO POLYAXIAL SCREW AT EITHER L4 OR L5 WAS SEEN TO BE FRACTURED DURING THE PATIENT'S SCHEDULED SIX-MONTH POST-OPERATIVE CHECK-UP. THE PATIENT HAS EXPERIENCED NO ADVERSE CONSEQUENCE AND REVISION IS NOT DEEMED NECESSARY BY THE PHYSICIAN.

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

  MAUDE report 10463218 ↗
• InjuryAug 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT A SERRATO POLYAXIAL SCREW FRACTURED POST-OPERATIVELY. THE PATIENT IS EXPERIENCING BACK PAIN, HOWEVER, THERE ARE NO PLANS FOR REVISION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 10374999 ↗
• MalfunctionAug 21, 2019Break; Fracture; Fracture

  A PHYSICIAN REPORTED THAT, WHILE IMPLANTING A 6.5 MM SERRATO PEDICLE SCREW AT L-5 S1, THE PEDICLE BROKE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING THE SAME SERRATO PEDICLE SCREW AT THE SAME LEVEL; NO EXTENSION OF THE CONSTRUCT WAS NECESSARY. THIS EVENT RESULTED IN A 10-MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915179 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON SCREW INSERTION L4 PEDICLE OUTER SIDE IS CRACKED. L4 WAS SKIPPED, CONSTRUCT EXTENDED TO FROM L3 TO L5. THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION. THE MAJOR DAMAGE TO THE BONE WAS REPORTED.

  Patient problems: Injury; Tissue Damage

  MAUDE report 8048397 ↗