Sniper® Spine System 11-4646Recalls & reported problems
Spine Wave, Inc. · Cannulated Extended Tab Pedicle Screw 6.5mm x 45mm · 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 10840642106442), received between Jun 4, 2018 and Jun 26, 2018 — classified as 1 injury, 1 malfunction.
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
- Material Separation1
Patient problems
- Fall1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2018Break
APPROXIMATELY ONE YEAR POST-OPERATIVELY FOLLOWING A POSTERIOR LUMBAR INTERBODY FUSION, TWO BROKEN SCREWS IN A ONE LEVEL PEDICLE SCREW CONSTRUCT WERE NOTED ON RADIOGRAPH. A SURGICAL PROCEDURE WAS PERFORMED APPROXIMATELY SIX MONTHS LATER TO REMOVE THE PEDICLE SCREW CONSTRUCT INCLUDING THE BROKEN SCREW HEADS, THE TWO RODS AND FOUR LOCKING CAPS. THE SURGEON DID NOT REPLACE THE CONSTRUCT. THE SURGEON HAS NOTED THAT THIS PATIENT EXPERIENCED A FALL WHILE SKIING A SHORT TIME AFTER THE INITIAL IMPLANT SURGERY WHICH HE HAS ASSOCIATED TO THIS EVENT.
Patient problems: Fall
MAUDE report 7639645 ↗MalfunctionJun 4, 2018Material Separation
DURING PLACEMENT OF A PEDICLE SCREW FOR LUMBAR FIXATION, THE SURGEON EXPERIENCED DIFFICULTY REDUCING THE ROD AT THE L4-L5 LEVEL. SUBSEQUENTLY, THE SURGEON NOTICED THE SCREW WAS SEPARATED. THE SCREW WAS REMOVED AND REPLACED INTRAOPERATIVELY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7567462 ↗
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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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