StaXx® XD System 11-1751Recalls & reported problems
Spine Wave, Inc. · Cartridge Lordotic Expandable Implant 25x9x8mm 15deg · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840642100877), received between May 31, 2017 and May 31, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Loose or Intermittent Connection1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2017Break; Loose or Intermittent Connection
PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2014 IN CONJUNCTION WITH BILATERAL PEDICLE SCREWS. PATIENT REPORTED THAT APPROXIMATELY EARLY (B)(6) 2016, HE DEVELOPED MARKED SEVERE PAIN. PATIENT WAS DIAGNOSED WITH A NON-UNION/PSEUDARTHROSIS, LOOSENING OF L5 BILATERAL PEDICLE SCREWS, BREAKAGE OF THE STAXX DEVICE (WITH COMPONENT RETROPULSION), AND MILD TO MODERATE RIGHT FORAMINAL STENOSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE AND REPLACE THE BROKEN STAXX DEVICE. ON (B)(6) 2016, THE PEDICLE SCREW SYSTEM WAS REMOVED AND REPLACED. IT WAS REPORTED THAT THE RETROPULSED COMPONENTS OF THE STAXX DEVICE REMAIN IN THE PATIENT.
Patient problems: Pain
MAUDE report 6603233 ↗
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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