ES2 SPINAL SYSTEM 482807045Recalls & reported problems
Stryker Corporation · STRAIGHT ROD · Class 2 · Implant
Data updated Oct 13, 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 07613327001464), received between Jun 4, 2020 and Sep 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Insufficient Device Problem Information1
Patient problems
- Injury1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2025Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration
UPON INSPECTION OF AN ADDITIONAL RETURNED XIA 3 BLOCKER, IT WAS OBSERVED THAT THE BLOCKER ALSO SHOWS SIGNS OF MIGRATION. THIS REPORT CAPTURES THE ES2 ROD.
Patient problems: Insufficient Information
MAUDE report 23144950 ↗InjuryJun 4, 2020Migration; Migration
IT WAS REPORTED THAT 4 MANTIS REDUX BLOCKERS AND 2 RODS, IMPLANTED IN L2/L3, MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS REPORT REPRESENTS THE SECOND OF THE TWO RODS.
Patient problems: Injury
MAUDE report 10121317 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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