XIA 3 48233550Recalls & reported problems
Stryker Corporation · UNIPLANAR SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327001051), received between Jul 20, 2016 and Jul 20, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component2
- Mechanical Problem2
Patient problems
- No Code Available2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2016Detachment Of Device Component; Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT; DURING THE DVR PROCEDURE, TUBES WERE USED WITHOUT CLAM SHELLS. STANDARD BLOCKER INSTER WAS USED INSTEAD OF TORQUE WRENCH. AFTER PROCEDURE WAS COMPLETED IT WAS NOTICED IN XRAY THE 2 TULIP HEADS HAD POPPED OFF FROM THE SCREW POST. SCREWS WERE REPLACED NO FURTHER ISSUES. UPDATE: PER ADDITIONAL CORRESPONDENCE WITH SALES REP, THE CAVITY WAS OPEN AND THERE WAS NO NEED TO REOPEN THE PATIENT AT THE TIME THE REPORTED EVENT WAS NOTICED.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5808733 ↗MalfunctionJul 20, 2016Detachment Of Device Component; Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT; DURING THE DVR PROCEDURE, TUBES WERE USED WITHOUT CLAM SHELLS. STANDARD BLOCKER INSTER WAS USED INSTEAD OF TORQUE WRENCH. AFTER PROCEDURE WAS COMPLETED IT WAS NOTICED IN XRAY THE 2 TULIP HEADS HAD POPPED OFF FROM THE SCREW POST. SCREWS WERE REPLACED NO FURTHER ISSUES. UPDATE: PER ADDITIONAL CORRESPONDENCE WITH SALES REP, THE CAVITY WAS OPEN AND THERE WAS NO NEED TO REOPEN THE PATIENT AT THE TIME THE REPORTED EVENT WAS NOTICED.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5808596 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page