aprevo 1300Recalls & reported problems
Carlsmed, Inc. · aprevo® Inserter, TLIF-C Articulating · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810056991852), received between Jan 14, 2025 and Jan 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Break; Break
THE NECK OF THE LOCKING KNOB USED TO LOCK THE IMPLANT IN THE INSERTION POSITION BROKE DURING IMPACTION ALLOWING THE IMPLANT TO BECOME UNLOCKED FROM THE INSERTION POSITION. THIS WOULD ALLOW THE IMPLANT TO MOVE INTO THE ARTICULATING POSITION. NO HARM TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149682 ↗MalfunctionJan 14, 2025Break; Break
THE NECK OF THE LOCKING KNOB USED TO LOCK THE IMPLANT IN THE INSERTION POSITION BROKE DURING IMPACTION ALLOWING THE IMPLANT TO BECOME UNLOCKED FROM THE INSERTION POSITION. THIS WOULD ALLOW THE IMPLANT TO MOVE INTO THE ARTICULATING POSITION. NO HARM TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149681 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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