ES2 SPINAL SYSTEM 482806070Recalls & reported problems
Stryker Corporation · RAD 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 07613327001679), received between Jul 25, 2016 and Jul 25, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment Of Device Component1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2016Break; Detachment Of Device Component; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT; HEX END BROKEN OFF FROM A 5.5MM RAD ROD 70MM. DOC HAD TO REPOSITION THE ROD, SO WHEN HE WENT TO RE-ENGAGE WITH THE ROD INSERTER, I NOTICED THE HEX END WAS STILL INSIDE THE ROD INSERTER. WAS ABLE TO GET THE ROD OUT WITH A LONG KELLY, AND WE USED ANOTHER SAME SIZE ROD WITH NO INCIDENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 5821007 ↗
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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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