Sniper® Spine System 11-4002Recalls & reported problems
Spine Wave, Inc. · Locking Screw, Extended Tab · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10840642105605), received between Feb 6, 2019 and Jun 15, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Slipped1
- Material Separation1
- Separation Failure1
Patient problems
- Failure of Implant2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2023Separation Failure; Separation Failure
AT AN UNSPECIFIED TIME POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO ADDRESS A LOOSE LOCKING SCREW IN A PEDICLE SCREW CONSTRUCT THAT WAS IDENTIFIED ON RADIOGRAPH.
Patient problems: Failure of Implant
MAUDE report 17139881 ↗InjuryJan 6, 2021Detachment of Device or Device Component
APPROXIMATELY 5 MONTHS POST-OPERATIVELY DURING ROUTINE FOLLOW-UP, IT WAS NOTED ON RADIOGRAPH THAT LOCKING SCREWS APPEARED TO BE SEPARATED FROM THE CONSTRUCT. A SURGICAL PROCEDURE WAS PERFORMED AT WHICH TIME THE SURGEON REPLACED THE LOCKING SCREWS AND A SINGLE PEDICLE SCREW.
Patient problems: Failure of Implant
MAUDE report 11127762 ↗InjuryMay 3, 2019Device Slipped
A SINGLE LOOSE LOCKING SCREW WAS IDENTIFIED APPROXIMATELY 17 MONTHS POST-OPERATIVELY FOLLOWING THE EXTENSION OF A PEDICLE SCREW CONSTRUCT. A REOPERATION WAS PERFORMED TO REMOVE AND REPLACE THE AFFECTED HARDWARE.
Patient problems: No Code Available
MAUDE report 8580004 ↗MalfunctionFeb 6, 2019Material Separation
DURING A SURGICAL PROCEDURE TO EXTEND AN EXISTING CONSTRUCT, IT WAS REPORTED THAT THE SURGEON NOTED TWO SEPARATED LOCKING SCREWS. THE FIXATION CONSTRUCT WAS REPLACED DURING THIS PROCEDURE. THE SURGEON REPORTED THAT THE ORIGINAL SURGERY HAD BEEN PERFORMED APPROXIMATELY TWO YEARS EARLIER AND THE PATIENT WAS FUSED AT THE ORIGINAL OPERATIVE LEVEL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8311302 ↗
Other Orthosis, Spinal Pedicle Fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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