DFINE® 00884450296523Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450296523), received between Mar 6, 2020 and Mar 6, 2020 — 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.

• MalfunctionMar 6, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VERTEBRAL AUGMENTATION [KYPHOPLASTY] POST-PROCEDURE, THE TIP OF THE NAVIGATING OSTEOTOME DETACHED WITHIN THE PATIENT'S VERTEBRAL BODY. THE FIRST LEVEL AUGMENTATION WAS SUCCESSFUL. DURING THE SECOND LEVEL AUGMENTATION THE PHYSICIAN NOTICED THAT THE OSTEOTOME WOULD NOT ARTICULATE. AFTER A FEW MINUTES OF MANIPULATION, THE DEVICE WAS SUCCESSFULLY REMOVED HOWEVER, THE PHYSICIAN NOTED THAT THE TIP HAD DETACHED WITHIN THE PATIENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT'S VERTEBRAL BODY. FLUOROSCOPY DEMONSTRATED THAT THE BROKEN TIP WAS WEDGED WITHIN A VERTEBRAL PEDICLE. THE PHYSICIAN DID NOT WANT TO ATTEMPT A PEDICLE PLASTY. THE PATIENT WAS DISCHARGED WITHOUT ADDITIONAL CONSEQUENCES. THE PHYSICIAN WILL CONTINUE TO MONITOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 9799476 ↗