ES2 SPINAL SYSTEM 48280310Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREWDRIVER · Class 1
All models of ES2 SPINAL SYSTEM (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540710475), received between Apr 4, 2017 and Jun 6, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Residue After Decontamination” (2 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 16, 2026.
Most reported problems
Device problems
- Residue After Decontamination2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2023Residue After Decontamination; Residue After Decontamination
A COMPANY REPRESENTATIVE REPORTED THAT A PROCEDURE WAS NOT ABLE TO BE COMPLETED AS PLANNED DUE TO RESIDUE FOUND IN THE SHAFTS OF TWO ES2 POLYAXIAL SCREWDRIVERS. THE PATIENT WAS CLOSED AND PRESCRIBED ANTIBIOTICS TO TREAT ANY POTENTIAL INFECTION. THE PATIENT WILL BE RESCHEDULED FOR A FUTURE SURGERY. THIS REPORT IS FOR THE SECOND OF TWO ES2 POLYAXIAL SCREWDRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070711 ↗InjuryJun 6, 2023Residue After Decontamination; Residue After Decontamination
A COMPANY REPRESENTATIVE REPORTED THAT A PROCEDURE WAS NOT ABLE TO BE COMPLETED AS PLANNED DUE TO RESIDUE FOUND IN THE SHAFTS OF TWO ES2 POLYAXIAL SCREWDRIVERS. THE PATIENT WAS CLOSED AND PRESCRIBED ANTIBIOTICS TO TREAT ANY POTENTIAL INFECTION. THE PATIENT WILL BE RESCHEDULED FOR A FUTURE SURGERY. THIS REPORT IS FOR THE FIRST OF TWO ES2 POLYAXIAL SCREWDRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070710 ↗MalfunctionApr 4, 2017Defective Component; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; LOCKING MECHANISM OF THE SCREWDRIVER DEFECTIVE. THEREFORE THE SCREW WAS INSERTED WITH HIGH PRESSURE ON THE SCREWDRIVER. SCREW LOOSENED AND MUST BE REPLACED DURING MEDICAL PROCEDURE. ANOTHER SCREW WAS AVAILABLE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6458251 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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