StaXx® XD System 11-1550Recalls & reported problems
Spine Wave, Inc. · Cartridge Lordotic Expandable Implant 22x9x7mm 8deg · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840642100686), received between Sep 4, 2018 and Dec 14, 2023 — classified as 3 injuries.
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
- Device Dislodged or Dislocated1
- Material Separation1
Patient problems
- Failure of Implant2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2023Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated
A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 18328807 ↗InjuryAug 8, 2019Detachment of Device or Device Component
THE SURGEON REPORTED THAT ON IMMEDIATE POST-OPERATIVE FLUOROSCOPY IMAGES, THE IMPLANT CONSTRUCT APPEARED TO BE SEPARATED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO REMOVE THE CONSTRUCT. THE SURGERY WAS SUCCESSFULLY PERFORMED.
Patient problems: Failure of Implant
MAUDE report 8875545 ↗InjurySep 4, 2018Detachment of Device or Device Component
AT AN UNSPECIFIED TIME POST-OPERATIVELY, THE SURGEON NOTED THAT THE IMPLANT CONSTRUCT HAD SEPARATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE CONSTRUCT.
Patient problems: No Information
MAUDE report 7844105 ↗
Other Spinal Vertebral Body Replacement Device devices
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- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 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 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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