Navigation Enabled 48702681Recalls & reported problems
Stryker Corporation · Serrato-ES2-Xia 3 Driver, Cannulated · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327460964), received between Sep 27, 2024 and Mar 8, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (3 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert3
- Detachment of Device or Device Component1
- Fracture1
- Naturally Worn1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Spinal Column Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2026Fracture; Difficult to Insert; Naturally Worn
INSPECTION OF THE RETURNED DEVICE INDICATES THAT SEVERAL PRONGS ON THE DEVICE TIP HAD FRACTURED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24542057 ↗MalfunctionSep 3, 2025Difficult to Insert; Difficult to Insert
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954502 ↗MalfunctionDec 19, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
IT WAS REPORTED THAT A XIA NAVIGATION ENABLED DRIVER WAS DISENGAGING FROM SCREWS INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20984366 ↗InjurySep 27, 2024Unstable; Unstable
IT WAS REPORTED THAT A NAVIGATION ENABLED SERRATO/ES2/XIA 3 CANNULATED DRIVER DISENGAGED FROM THE SCREW DURING PLACEMENT AT S1. THIS ALTERED THE TRAJECTORY OF THE SCREW AND MADE THE SCREW HOLE TOO LARGE. THE SURGEON OPTED TO PLACE A SCREW IN THE LEFT ILIAC BONE INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20-MINUTE SURGICAL DELAY AND NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: Spinal Column Injury
MAUDE report 20322654 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.