aprevo H.L23.02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810056990763), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2023 AN EVENT WAS REPORTED BY CARLSMED'S DIRECTOR OF SALES, (B)(4), REGARDING DR. (B)(6) CASE WITH LOT CODE, 230504.BK.01 PERFORMED ON (B)(6) 2023. THE CASE WAS PLANNED WITH A SINGLE LEVEL L23 APREVO TLIF-OBLIQUE (LEFT SIDED APPROACH). THE DATE OF THE EVENT WAS (B)(6) 2023. DURING THE PLACEMENT OF THE L23 TLIF-O INTERVERTEBRAL BODY FUSION DEVICE (REFERRED TO AS THE 'DEVICE' IN THIS SECTION), THE DEVICE ROTATED MEDIALLY TOWARDS THE SPINAL CORD. THE CORNER EDGE OF THE DEVICE CAME INTO CONTACT WITH THE ANATOMY OF THE SPINAL CORD, RESULTING IN A DURAL TEAR. THE TEAR REQUIRED INTERVENTION, AND THE SURGEON SPENT AN ADDITIONAL 10-15 MINUTES TO REPAIR THE DURAL TEAR. IT WAS REPORTED THAT THE DEVICE WAS FULLY SEATED AND THREADED ONTO THE INSTRUMENT. ACCORDING TO THE SURGEON, THE PATIENT IS IN GOOD CONDITION WITH NO REPORTS OF ANY LONG TERM SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286756 ↗