XIA 3 482365540Recalls & reported problems
Stryker Corporation · UNIPLANAR REDUCTION SCREW · Class 2 · Implant
All models of XIA 3 (93)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327001358), received between Sep 26, 2018 and Jan 16, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Separation2
- Break1
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVISION SURGERY TO ADDRESS DISTAL JUNCTION KYPHOSIS, THE SURGEON NOTED TULIP DISENGAGEMENTS OF THREE OF THE PREVIOUSLY IMPLANTED XIA UNIPLANAR REDUCTION SCREWS. THE SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE FIRST OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18518762 ↗MalfunctionJan 16, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVISION SURGERY TO ADDRESS DISTAL JUNCTION KYPHOSIS, THE SURGEON NOTED TULIP DISENGAGEMENTS OF THREE OF THE PREVIOUSLY IMPLANTED XIA UNIPLANAR REDUCTION SCREWS. THE SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE THIRD OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18518761 ↗InjurySep 26, 2018Break; Fracture; Loose or Intermittent Connection; Fracture
BROKEN PEDICAL SCREW WAS REMOVED FROM L1 ON LEFT SIDE. BLOCKER CAME LOOSE FROM PEDICAL SCREW ON L1 ON RIGHT SIDE. PEDICAL SCREW ON RIGHT WAS ALSO REMOVED. NEW PEDICLE SCREWS WERE PLACED ON BOTH SIDES AT L2 AND 4 CONNECTORS WERE USED TO CONNECT L2 TO EXISTING ROD.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 7912279 ↗
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 14, 2026 · each report above links to its original FDA record
- 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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