NA 394.572Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034777337), received between Feb 2, 2017 and Aug 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE DEVICE HANDLE CHIPPED DURING A SPINAL FUSION PROCEDURE TO TREAT DEGENERATIVE DISC DISEASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GRAFT PUSHER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368581 ↗
• MalfunctionFeb 2, 2017Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED THAT A GRAFT PUSHER 8MM HANDLE WAS NOTICED TO BE FLAKING OFF WHILE CLEANING. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. DUE TO THE MATERIAL DECOMPOSITION, IT WAS DETERMINED THE DEVICE WAS NOT FIT FOR SURGERY ANYMORE. WHILE THE DEVICE WAS BEING EVALUATED BY THE MANUFACTURER IT WAS NOTED THAT THE DEVICE HAS A BROKEN HANDLE WITH FRAGMENTS MISSING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6297004 ↗