ES2 SPINAL SYSTEM 482807065Recalls & reported problems
Stryker Corporation · STRAIGHT ROD · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327001501), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2020Fracture; Fracture
IT WAS REPORTED THAT AN ES2 HEX STRAIGHT ROD FRACTURED POST-OPERATIVELY. DURING INTRA-OPERATIVE ROD ADJUSTMENT, THE SURGEON HAD DIFFICULTY ATTACHING AND DETACHING THE ROD INSERTER. AFTER MUCH TRAIL AND ERROR THE INSERTER WAS ABLE TO FORCIBLY BE REMOVED. INTRA-OPERATIVE IMAGING WAS PERFORMED AND FOUND NO DEVICE ISSUE. HOWEVER, POST-OPERATIVE IMAGING REVEALED THE RIGHT ROD HEX (CRANIAL SIDE) WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. REVISION SURGERY HAS NOT BEEN SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10838653 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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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