Salvo® Spine System 11-6400Recalls & reported problems
Spine Wave, Inc. · Yoke, 5.5/6.0 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10840642163711), received between Oct 18, 2023 and Jan 7, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Premature Separation3
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- Failure of Implant4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Detachment of Device or Device Component
APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY, THE SURGEON REPORTED THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH LEGS AND LOWER BACK. A SURGICAL PROCEDURE WAS PERFORMED. AT THAT TIME, THE SURGEON OBSERVED ONE PEDICAL SCREW YOKE DISENGAGED FROM ONE BONE SCREW IN THE PEDICLE SCREW CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 23996041 ↗InjuryJul 3, 2024Premature Separation; Premature Separation
FOLLOWING A PATIENT FALL, A POST-OPERATIVE RADIOGRAPH IDENTIFIED A PEDICLE SCREW YOKE DISENGAGED FROM THE SCREW SHANK. A PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE.
Patient problems: Failure of Implant
MAUDE report 19668003 ↗InjuryJan 18, 2024Premature Separation; Premature Separation
DURING ROUTINE POST-OPERATIVE RADIOGRAPHIC IMAGING, A PEDICLE SCREW YOKE WAS OBSERVED TO BE UN-ENGAGED TO THE SCREW SHANK. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE AFFECTED PART.
Patient problems: Failure of Implant
MAUDE report 18539568 ↗InjuryJan 5, 2024Premature Separation; Premature Separation
DURING POST-OPERATIVE RADIOGRAPHIC IMAGING A PEDICLE SCREW YOKE WAS OBSERVED TO BE UN-ENGAGED TO THE SCREW SHANK. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE THE HARDWARE.
Patient problems: Failure of Implant
MAUDE report 18449964 ↗MalfunctionOct 18, 2023Separation Failure; Separation Failure
DURING A REVISION SURGERY OF AN EXISTING LONG CONSTRUCT UNRELATED TO THE MANUFACTURER'S DEVICE, TWO SCREW YOKES WERE FOUND UN-ENGAGED TO THE SCREW HEADS.
Patient problems: Failure of Implant
MAUDE report 17958568 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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