CoRoent 6921055Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517393708), received between Jan 24, 2024 and Oct 22, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Fracture; Fracture

  DURING A LUMBAR PROCEDURE WHEN INSERTING THE INTERBODY SPACER INTO THE DISC SPACE, THE DEVICE FRACTURED. A SECOND DEVICE WAS USED AND THE CASE WAS ABLE TO BE COMPLETED NO IMPACT TO THE PATIENT OR CASE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510099 ↗
• InjuryMay 2, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2024 A PATIENT UNDERWENT LATERAL INTERBODY FUSION PROCEDURE ON UNCONFIRMED OF THE LUMBAR SPINE. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE FOLLOWING THE PROCEDURE THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING DURING EXAMINATION AND IMAGING DISCOVERED THE VERTEBRAL SPACER AT THE L4/L5 LEVEL HAD MIGRATED. ON (B)(6) 2024 A REVISION OCCURRED WHERE THE MIGRATED CAGE WAS REPLACED. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT. MULTIPLE RADIOGRAPHS WERE PROVIDED FOR REVIEW FROM POST THE INDEX PROCEDURE AND PRE REVISION PROCEDURE. THESE RADIOGRAPHS WERE REVIEWED BY NUVASIVE'S DIRECTOR OF MEDICAL AFFAIRS AND HE OBSERVED WHAT APPEARED TO BE A COMPRESSION FRACTURE OF THE L4 VERTEBRAL BODY INVOLVING THE SUPERIOR ENDPLATE. IN ADDITION TO THE MIGRATED VERTEBRAL SPACER THAT WAS REPORTED AT THE L4/L5 LEVEL IT WAS ALSO OBSERVED THE SPACER AT L3/L4 HAD EXPERIENCED MIGRATED INTO THE DISC SPACE AND SUBSIDED. 2 OF 2

  Patient problems: Ambulation or Postural Difficulties; Vertebral Fracture

  MAUDE report 19233557 ↗
• MalfunctionMay 2, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2024 A PATIENT UNDERWENT LATERAL INTERBODY FUSION PROCEDURE ON UNCONFIRMED OF THE LUMBAR SPINE. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE FOLLOWING THE PROCEDURE THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING DURING EXAMINATION AND IMAGING DISCOVERED THE VERTEBRAL SPACER AT THE L4/L5 LEVEL HAD MIGRATED. ON (B)(6) 2024 A REVISION OCCURRED WHERE THE MIGRATED CAGE WAS REPLACED. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT. 1 OF 2.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19233380 ↗
• MalfunctionJan 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON ATTEMPTED TO PLACE THE IMPLANT INTO THE INTRAVERTEBRAL SPACE, THE INTERBODY FRACTURED INTO MULTIPLE PIECES AT THE PROXIMAL END OF THE IMPLANT, WHERE THE INTERBODY CONNECTED TO THE INSERTER. IT WAS NOTED THE IMPLANT WAS LARGER THAN THE AVAILABLE INTERVERTEBRAL SPACE AND THE SURGEON USED FORCE IN AN EFFORT TO PLACE IT IN THE SPACE. THE IMPLANT PIECES WERE REMOVED AND DISCARDED IN THE OPERATIVE ROOM. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576526 ↗