ES2 SPINAL SYSTEM 482806060Recalls & reported problems
Stryker Corporation · RAD ROD · Class 2 · Implant
All models of ES2 SPINAL SYSTEM (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327001662), received between Jul 9, 2020 and Jul 9, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.
Most reported problems
Device problems
- Biocompatibility2
Patient problems
- Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2020Biocompatibility; Biocompatibility
A SURGEON REPORTED THAT A PATIENT MAY HAVE EXPERIENCED METALLOSIS AT THE L4 LEVEL WHILST IMPLANTED WITH TWO ES2 SCREWS AND TWO ES2 HEX RODS. THE PATIENT WAS UNDERGOING A SCHEDULED REVISION SURGERY TO EXTEND THE CONSTRUCT TO S1 WHEN THE SURGEON NOTED, "METALLOSIS AROUND THE L4 SCREWS," AND, "SOME EVIDENCE OF DISCOLOURATION OF THE SURROUNDING TISSUE ADJACENT TO THE SCREWS." SURGERY WAS COMPLETED AS PLANNED; THE RODS WERE EXPLANTED AND REPLACED WITH LONGER RODS AND THE L4 SCREWS WERE REPLACED. THIS REPORT REPRESENTS THE SECOND OF THE TWO RODS.
Patient problems: Injury
MAUDE report 10254843 ↗InjuryJul 9, 2020Biocompatibility; Biocompatibility
A SURGEON REPORTED THAT A PATIENT MAY HAVE EXPERIENCED METALLOSIS AT THE L4 LEVEL WHILST IMPLANTED WITH TWO ES2 SCREWS AND TWO ES2 HEX RODS. THE PATIENT WAS UNDERGOING A SCHEDULED REVISION SURGERY TO EXTEND THE CONSTRUCT TO S1 WHEN THE SURGEON NOTED, "METALLOSIS AROUND THE L4 SCREWS," AND, "SOME EVIDENCE OF DISCOLOURATION OF THE SURROUNDING TISSUE ADJACENT TO THE SCREWS." SURGERY WAS COMPLETED AS PLANNED; THE RODS WERE EXPLANTED AND REPLACED WITH LONGER RODS AND THE L4 SCREWS WERE REPLACED. THIS REPORT REPRESENTS THE FIRST OF THE TWO RODS.
Patient problems: Injury
MAUDE report 10254799 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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