CoRoent 6171060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517292773), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.

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.

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.

• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3 TO L5 WITH PERCUTANEOUS POSTERIOR FIXATION. SUBSEQUENTLY, APPROXIMATELY SIX (6) WEEKS LATER, IT WAS NOTED THAT THE PATIENT HAD SUFFERED POSTOPERATIVE COMPLICATIONS THAT REQUIRED SEQUENTIAL RE-OPERATIONS INCLUDING A STAPHYLOCOCCUS INFECTION, PAIN, AND CANAL COMPRESSION. INFORMATION REGARDING THE DATE(S), QUANTITY, AND NATURE OF THE RE-OPERATIONS WAS NOT PROVIDED; HOWEVER, IT WAS NOTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE L3/L4 INTERBODY VIA AN ANTERIOR APPROACH AND REPLACE WITH AN ANTERIOR LUMBAR INTERBODY FUSION WITH INTERFIXATION. FOLLOWING THE REVISION, IT WAS NOTED THAT THE PATIENT HAD ABDOMINAL BLEEDING AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. ADDITIONAL INFORMATION REPORTED THE PATIENT'S CONDITION HAS IMPROVED. THE SURGEON DOES NOT BELIEVE THE COMPLICATIONS WERE RELATED TO THE PRODUCTS USED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 18927274 ↗