XIA 3 482318545Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540598592), received between Apr 13, 2016 and Jan 7, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation3
- Break2
- Detachment of Device or Device Component2
- Material Integrity Problem2
- Device Dislodged or Dislocated1
- Device Slipped1
- Fracture1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Known Impact Or Consequence To Patient5
- Injury1
- No Code Available1
- Numbness1
- Pain1
- Spinal Column Injury1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated
MalfunctionSep 21, 2018Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE ROD WAS INSERTED INTO THE SCREW HEAD WITH A PERSUADER, THE SCREW HEAD CAME OFF THE SCREW SHAFT. THE SCREW AND ROD WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO BROKEN FRAGMENTS. THERE WAS A SURGICAL DELAY OF HONE HOUR AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898479 ↗MalfunctionJul 17, 2017Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; 8.5 SCREW SPLAYED OPEN DURING FINAL TIGHTENING
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6720060 ↗MalfunctionJul 5, 2017Mechanical Problem; Mechanical Problem; Device Slipped
IT WAS REPORTED THAT; SCREW HEAD POPPED OFF WHEN FINAL TIGHTENING BLOCKER. REPLACED SCREW WITH ANOTHER 8.5 X 50 SCREW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6687933 ↗InjuryMay 19, 2017Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size; Migration or Expulsion of Device
IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY AND COMPLAINED OF PAIN AND NUMBNESS AFTER THE SURGERY. THE SURGEON NOTICED THAT THE SCREW WHICH WAS IMPLANTED IN S1 WAS CONTACTING TO NERVE. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. THE INSERTION DIRECTION OF THE SCREW WAS CHANGED, THE SCREW SIZE WAS CHANGED WITH 8.5×45 AND ROD LENGTH WAS ALSO CHANGED WITH 6.0×40 .
Patient problems: Injury; No Code Available; Numbness; Pain
MAUDE report 6578647 ↗MalfunctionMay 15, 2017Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT; SCREW TULIP SPLAYED OPEN WHILE BLOCKER WAS BEING FINAL TIGHTENED WITH A STANDARD TORQUE WRENCH. THE DELAY WAS ONE MINUTE. SURGEON REMOVED THE CAP AND INSERTED IT AGAIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6567276 ↗MalfunctionApr 13, 2016Break; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW SPLAYED OPEN DURING BLOCKER INSERTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5574741 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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