NuVasive 1001992Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517045928), received between May 18, 2023 and May 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• MalfunctionMay 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L3/4 AND L4/5. DURING THE PROCEDURE, WHEN THE PADDLE SIZER WAS INSERTED INTO THE INTRAVERTEBRAL SPACE AND SLIGHTLY TWISTED, THE ATTACHED HUDSON T-HANDLE FRACTURED AT THE MATING INTERFACE WITH THE PADDLE SIZER. THE FRACTURED PORTION WAS SEARCHED FOR BUT WAS UNABLE TO BE LOCATED WITHIN THE PATIENT. INFORMATION REGARDING WHETHER IMAGES WERE USED TO CONFIRM IF THE PIECE WAS IN THE PATIENT OR NOT WAS REQUESTED BUT WAS NOT AVAILABLE. THEREFORE, IT COULD NOT BE DETERMINED IF THE FRACTURED PIECE WAS RETAINED BY THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16958118 ↗