RADIUS 486613602Recalls & reported problems
Stryker Corporation · VITALLIUM SPINAL ROD, WITH HEX · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540604859), received between Mar 7, 2017 and Apr 5, 2024 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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
- Fracture6
- Break2
- Bent1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- Injury1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 8 YEARS POST-OPERATIVELY, IMAGING REVEALED A XIA POLYAXIAL SCREW TIP FRACTURE AND THE FRACTURE OF TWO RADIUS VITALLIUM RODS. THIS REPORT CAPTURES THE FIRST OF TWO RADIUS VITALLIUM RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056054 ↗InjuryApr 5, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 8 YEARS POST-OPERATIVELY, IMAGING REVEALED A XIA POLYAXIAL SCREW TIP FRACTURE AND THE FRACTURE OF TWO RADIUS VITALLIUM RODS. THIS REPORT CAPTURES THE SECOND OF TWO RADIUS VITALLIUM RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056052 ↗InjuryMay 3, 2023Fracture; Migration; Fracture; Migration
A PATIENT REPORTED A FRACTURED RADIUS VITALLIUM ROD ON THE RIGHT SIDE OF THEIR CONSTRUCT. IMAGING SHOWS THE FRACTURED DEVICE HAS MIGRATED AND PATIENT REPORTS THAT THEY ARE AMBULATORY BUT IN PAIN. REVISION SURGERY IS NOT CURRENTLY PLANNED.
Patient problems: Pain
MAUDE report 16862848 ↗InjuryFeb 25, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT THE ROD WAS BROKEN POST- OPERATIVELY. PATIENT UNDERWENT REVISION SURGERY FOR ROD BREAKAGE AND POSSIBLE NON-UNION.
Patient problems: Failure of Implant; Injury
MAUDE report 8366832 ↗MalfunctionApr 10, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY FOR T4- ILIAC, THE ROD BROKE WHEN THE SURGEON WAS BENDING IT OVER THE PATIENT. THE SURGEON USED ANOTHER ROD TO COMPLETE THE SURGERY. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7419352 ↗MalfunctionMar 7, 2017Bent; Fracture; Fracture
IT WAS REPORTED THAT; DURING SURGERY, THE ROD WAS CUT ON THE BACK TABLE WITH TOP CUTTER. WHEN THE ROD WAS BENT ON THE MAYO WITH FRENCH BENDER, IT SNAPPED IN HALF. ANOTHER ROD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6384299 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
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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