Sniper® Spine System 11-4001Recalls & reported problems
Spine Wave, Inc. · Locking Screw · 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 10840642105599), received between Dec 28, 2016 and May 8, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2018Loose or Intermittent Connection
DURING A SURGICAL PROCEDURE TO EXTEND A PEDICLE SCREW CONSTRUCT, THE SURGEON NOTED LOOSE LOCKING SCREWS. THE ORIGINAL PEDICLE SCREW CONSTRUCT HAD BEEN IMPLANTED APPROXIMATELY EIGHTEEN MONTHS EARLIER. THE SURGEON REPLACED THE LOCKING SCREWS AND EXTENDED THE CONSTRUCT AS PLANNED.
Patient problems: Failure of Implant
MAUDE report 7496900 ↗InjuryDec 28, 2016Migration or Expulsion of Device; Device Dislodged or Dislocated
AT ROUTINE 6 MONTH FOLLOW UP, X-RAY IMAGING SHOWED A LOCKING SCREW AT L5 LEVEL APPEARED TO BE DISENGAGED. THE PATIENT WAS ASYMPTOMATIC. THE SURGEON CHOSE TO RE-INSTRUMENT DUE TO MIGRATION OF THE INTERBODY DEVICE (ANOTHER MANUFACTURER). THE SURGEON SUCCESSFULLY REMOVED AND REPLACED THE LOOSE LOCKING SCREW AND ADDITIONALLY ONE PEDICLE SCREW AND LOCKING SCREW AND THE INTERBODY DEVICE.
Patient problems: No Code Available
MAUDE report 6211357 ↗
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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