StaXx® XD System 11-1590Recalls & reported problems
Spine Wave, Inc. · Cartridge Lordotic Expandable Implant Ti 22x9x7mm 8deg · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840642100167), received between Jul 13, 2018 and Dec 5, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
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.
Most reported problems
Device problems
- Disconnection1
- Migration1
Patient problems
- Nerve Damage1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2019Disconnection
INTRAOPERATIVELY, THE SURGEON REPORTED NOTING THAT THE SECOND IMPLANT IN A BILATERAL CONSTRUCT APPEARED TO BE DISCONNECTED AFTER PLACEMENT. AS THE IMPLANT WAS SECURE, NO FURTHER ACTION WAS TAKEN AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9419553 ↗InjuryJul 13, 2018Migration
IT HAS BEEN REPORTED THAT THE DEVICE "WENT BACK INTO [THE PATIENT'S] SPINAL CANAL AND DAMAGED HIS NERVE". SUBSEQUENTLY, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. THE PATIENT HAS REPORTED SUFFERING FROM PAIN.
Patient problems: Nerve Damage; Pain
MAUDE report 7687098 ↗
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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