RADIUS 486613600Recalls & reported problems
Stryker Corporation · TITANIUM SPINAL ROD, WITH HEX · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540545831), received between Jan 14, 2019 and Apr 23, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- Back pain2
- Injury1
- No Information1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Fracture
InjuryApr 14, 2026Fracture
ADDITIONAL IMAGING PROVIDED FROM THE FIELD INDICATED THAT THREE RODS FRACTURED. THIS REPORT CAPTURES THE SECOND OF THREE RODS.
Patient problems: Back pain
MAUDE report 24877575 ↗InjuryDec 27, 2024Fracture; Fracture
HEALTH AUTHORITY RUSSIA REPORTED THAT A PATIENT WITH PAIN IS TO BE REVISED APPROXIMATELY 3 YEARS POST-OPERATIVELY TO ADDRESS THREE FRACTURED RODS. THIS REPORT CAPTURES THE RADIUS SPINAL ROD.
Patient problems: Pain
MAUDE report 21025600 ↗InjuryJan 14, 2019Device Dislodged or Dislocated; Migration; Migration
SURGEON SENT PICTURE OF PATIENT WHO ORIGINALLY HAD A T11-PELVIS FUSION ON (B)(6) 2018. IMAGE SHOWS BOTH RODS HAD POPPED OUT OF THE PELVIC SCREWS AND THE CAGE AT L4-L5 HAD BACKED OUT. REQUIRED REVISION OF FUSION (SCREWS ADDED AT S1; AND RODS RE-SEATED AND REVISED IN PELVIC BOLTS), EXTRACTION OF CAGE, AND CLOSURE OF DURAL TEAR AT L4/L5.
Patient problems: Injury; No Information
MAUDE report 8244446 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.