OASYS 48553240Recalls & reported problems
Stryker Corporation · VITALLIUM ROD · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540604910), received between Aug 29, 2016 and Aug 29, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Fracture2
- Material Integrity Problem2
Patient problems
- Injury2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; 2 VITALLIUM RODS BROKE. PATIENT REQUIRED A REVISION SURGERY.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 5912538 ↗InjuryAug 29, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; 2 VITALLIUM RODS BROKE. PATIENT REQUIRED A REVISION SURGERY.
Patient problems: Injury; No Code Available
MAUDE report 5912535 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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