Velocity™ Expandable Interbody System 11-2645Recalls & reported problems
Spine Wave, Inc. · Expandable Implant, 25(L) X 10(W) X 8-14(H) 8 Degree Lordotic · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840642106916), received between Dec 27, 2016 and Jan 17, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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 16, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device2
- Device Dislodged or Dislocated1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2019Migration or Expulsion of Device
AT AN UNSPECIFIED TIME POST-OPERATIVELY, THE SURGEON NOTED THAT THE IMPLANT CONSTRUCT HAD MIGRATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8259112 ↗InjuryDec 27, 2016Migration or Expulsion of Device; Device Dislodged or Dislocated
APPROXIMATELY THREE WEEKS POST-OPERATIVELY, A PATIENT REPORTED LEG PAIN. UPON IMAGING, IT WAS NOTED THAT THE INTERBODY IMPLANT HAD SHIFTED. THE SURGEON REMOVED THE IMPLANT IN ONE PIECE AND SUCCESSFULLY REPLACED IT WITH ANOTHER DEVICE.
Patient problems: Pain
MAUDE report 6206958 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
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- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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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