Velocity™ Expandable Interbody System 11-2644Recalls & reported problems
Spine Wave, Inc. · Expandable Implant, 22(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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840642106909), received between Apr 24, 2017 and Oct 6, 2021 — classified as 3 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
- Positioning Problem1
Patient problems
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2021Migration or Expulsion of Device
AT APPROXIMATELY THREE MONTHS POST-OPERATIVELY, THE SURGEON PERFORMED A SURGICAL PROCEDURE TO REMOVE AN IMPLANT THAT HAD MIGRATED.
Patient problems: Insufficient Information
MAUDE report 12586458 ↗InjurySep 21, 2021Migration or Expulsion of Device
AT APPROXIMATELY SEVEN WEEKS POST-OPERATIVELY, THE SURGEON NOTED THAT THE IMPLANT CONSTRUCT HAD MIGRATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 12509959 ↗InjuryApr 24, 2017Positioning Problem
APPROXIMATELY ONE MONTH POST-OPERATIVELY, IT WAS NOTED ON RADIOGRAPHIC EXAMINATION THAT THE DEVICE HAD SHIFTED. THE SURGEON REMOVED THE DEVICE IN ONE PIECE APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6517152 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- 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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