RADIUSRecalls & reported problems across all models
Stryker Corporation · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 13 models of RADIUS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between May 3, 2016 and Apr 23, 2026 — classified as 13 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RADIUS problems
Device problems
- Fracture21
- Break15
- Material Integrity Problem4
- Mechanical Problem4
- Migration4
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated3
- Device Slipped3
Patient problems
- No Known Impact Or Consequence To Patient16
- Injury7
- No Code Available6
- No Clinical Signs, Symptoms or Conditions5
- No Information3
- Pain3
- Back pain2
- Discomfort1
RADIUS models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RADIUS 486613602ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- RADIUS 486619100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- RADIUS 486613600APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- RADIUS 486614560APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- RADIUS 486619250ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- RADIUS 486614110APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- RADIUS 486613601APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- RADIUS 486619035ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RADIUS 486611640APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- RADIUS 486618745Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- RADIUS 486615020ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- RADIUS 486619085ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- RADIUS 486619095ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent RADIUS adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionNov 4, 2021Fracture; Fracture
A PHYSICIAN REPORTED THAT A RADIUS MULTI-ANGLE RAPID SCREW PLACED AT S1 FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS BEEN NEITHER PERFORMED OR SCHEDULED AND NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12750872 ↗InjuryOct 27, 2021Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT THE RADIUS VITALLIUM ROD FRACTURED AND MIGRATED POST-OPERATIVELY. UPON REVIEW OF THE PROVIDED IMAGING, IT WAS OBSERVED THAT THREE XIA BLOCKERS HAD LOOSENED AS WELL. REVISION SURGERY HAS BEEN PERFORMED. THIS RECORD CAPTURES THE FRACTURED RADIUS VITALLIUM ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704587 ↗MalfunctionMay 26, 2021Fracture; Fracture
DURING ROUTINE FOLLOW UP AFTER SURGERY IT WAS FOUND THAT THE PATIENT HAD BROKEN ROD, CONNECTOR, AND TULIP ON SCREW CAME OFF. THIS RECORD CAPTURES THE REPORTED FRACTURE OF A RADIUS ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886435 ↗InjuryApr 29, 2019Device Slipped; Migration; Migration
THE DEVICE WAS IMPLANTED (B)(6) 2016. THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT ATTRIBUTED TO THE CONCOMITANTLY IMPLANTED CAGE IN (B)(6) 2017. REVISION SURGERY WAS PERFORMED TO ADDRESS THE CONCOMITANT DEVICE ON (B)(6) 2019. DURING REVISION, THE PHYSICIAN NOTED THAT THIS DEVICE (L4 SCREW) WAS, "SLIGHTLY LOOSE," THEN REMOVED AND REPLACED IT.
Patient problems: Discomfort; Injury; Pain
MAUDE report 8563273 ↗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 ↗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 ↗MalfunctionAug 20, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE T HANDLE WAS PULLED TO CONNECT TO A PROBE SHAFT IN ORDER TO REMOVE THE SHAFT FROM THE PATIENT, THE T HANDLE BROKE UP. THERE WERE NO REMAINING BROKEN FRAGMENTS IN THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER T HANDLE. THERE ARE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7796610 ↗MalfunctionMay 31, 2018Break; Detachment Of Device Component; Fracture; Fracture
IT WAS REPORTED THAT THE DISTAL END OF PEDICLE PROBE BROKEN OFF IN PATIENT BONE. THIS OCCURRED IN THE S1 VERTEBRAL BODY WHILE SURGEON WAS PREPARING THE BONE FOR PEDICLE SCREW PLACEMENT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7558620 ↗MalfunctionMay 23, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT THE RADIUS HEIGHT ADJUSTER WAS DISCOVERED BROKEN POST SURGERY. THE INSTRUMENT WAS USED DURING SURGERY TO REMOVE A RADIUS RAPID SCREW. THE INSTRUMENT WAS ABLE TO SUCCESSFULLY REMOVE THE SCREW. IT IS UNKNOWN IF THE ADJUSTER BROKE DURING THE SURGERY. IT IS UNKNOWN IF ANY FRAGMENTS ENTERED THE PATIENT CAVITY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7538601 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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