Salvo™ Spine System 11-6530Recalls & reported problems
Spine Wave, Inc. · Yoke, 4.75 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10840642132984), received between Jul 20, 2020 and Jan 5, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material 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
- Material Separation3
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Detachment of Device or Device Component
APPROXIMATELY FIVE WEEKS POST-OPERATIVELY DURING ROUTINE RADIOGRAPHIC FOLLOW-UP, ONE PEDICLE SCREW YOKE WAS OBSERVED TO BE DISENGAGED FROM ONE BONE SCREW IN THE 2-LEVEL PEDICLE SCREW CONSTRUCT. THE SURGEON REPORTS THAT NO FURTHER SURGERY IS REQUIRED AS THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968071 ↗InjuryDec 2, 2020Material Separation
POST-OPERATIVELY, THE SURGEON IDENTIFIED A SEPARATED SCREW IN THE PEDICLE SCREW CONSTRUCT VIA RADIOGRAPH. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE YOKE WHILE LEAVING THE SCREW AND REMAINING CONSTRUCT IN PLACE.
Patient problems: Insufficient Information
MAUDE report 10931926 ↗MalfunctionNov 25, 2020Material Separation
DURING ROUTINE POST-OPERATIVE FOLLOW UP, FOUR WEEKS POST-OPERATIVELY, THE SURGEON IDENTIFIED A SEPARATED SCREW IN THE PEDICLE SCREW CONSTRUCT VIA RADIOGRAPH. THE PEDICLE SCREW AND CONSTRUCT WERE LEFT IN PLACE AS THE SURGEON REPORTED THE PATIENT IS ASYMPTOMATIC.
Patient problems: Insufficient Information
MAUDE report 10906766 ↗InjuryJul 20, 2020Material Separation
APPROXIMATELY FOUR MONTHS POST-OPERATIVELY, A PATIENT REPORTEDLY EXPERIENCED PAIN. A SURGICAL PROCEDURE WAS PERFORMED AT WHICH TIME THE SURGEON IDENTIFIED A SEPARATED SCREW IN THE PEDICLE SCREW CONSTRUCT. THE PEDICLE SCREW AND CONSTRUCT WERE REPLACED.
Patient problems: Pain
MAUDE report 10295474 ↗
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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